MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-07-19 for SMALL HALO CROWN HT035 manufactured by Depuy Synthes Spine.
[49910588]
Additional narrative: (b)(4). A follow up report will be filed upon completion of the investigation. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[49910589]
During application of a halo fixation system, the halo crown is fixed with 4 pins to the skull. One of these pins got wedged into the crown up to the point where not adequate fixation could be archived. As to how this event was solved is not exactly known yet. I can speak to the treating hcp next week. There was additional anesthesia needed for the skin of the patient and the procedure was lengthened. How much the procedure was lengthened is known at this time. The product as available for examination. This event is not uncommon to this user. Update 06 july 2016 - it seems that the threads in the ring are not correctly cut, as the pin jammed immediately in the ring.
Patient Sequence No: 1, Text Type: D, B5
[52572203]
Device manufacture date, evaluation codes: additional information. Device evaluated by mfr? : corrected data. (b)(4). Devices were not returned to the complaints handling unit (chu) for evaluation. Pictures of the halo crown were sent which revealed that the posterior pin holder threads were damaged / stripped. However, the damage cannot be confirmed without the return of the product. A review of the device history record was conducted. No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer. No emerging trends were found requiring further actions. Pictures of the halo crown were sent which revealed that the posterior pin holder threads were damaged / stripped. However, a definitive root cause cannot be determined with the provided information, as it cannot be confirmed that the product failed to meet specification. As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device not returned. Only photos.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2016-10497 |
| MDR Report Key | 5805010 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-07-19 |
| Date of Report | 2016-06-23 |
| Date of Event | 2016-06-23 |
| Date Mfgr Received | 2016-08-10 |
| Device Manufacturer Date | 2015-10-02 |
| Date Added to Maude | 2016-07-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASON BUSCH |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808201 |
| Manufacturer G1 | MEDOS INTERNATIONAL SARL |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMALL HALO CROWN |
| Generic Name | COMPONENT, TRACTION, INVASIVE |
| Product Code | JEC |
| Date Received | 2016-07-19 |
| Catalog Number | HT035 |
| Lot Number | 062008 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES SPINE |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-19 |