MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-01-15 for SKULL PIN 2000 PKG-5-STRL AC020 manufactured by Depuy Synthes Spine.
[17160198]
It was reported that a patient had been implanted with crown sliders and skull pin on (b)(6) 2013. A surgery to remove the devices was performed on (b)(6) 3013, after an anterior skill pin had backed out. During the removal, the skull pin anterior head could not be disassembled from the slider, and so the devices were removed. There were no adverse patient consequences as a result, and the physician intends to perform another halo system installation procedure on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
[17552286]
A follow-up report will be submitted upon completion of the investigation. The incident in this report is associated with the device reported in mfr report # 1526439-2014-10546.
Patient Sequence No: 1, Text Type: N, H10
[25564908]
Visual inspection noted that the two skull pins were still screwed into the 3d crown zero sliders. Various attempts to unscrew the skull pins were taken. However, it was very difficult to fully unscrew the skull pins. It appears that the skull pin threads have become ceased inside the sliders causing the skull pins not being able to unscrew. A review of the device history record (dhr) for the skull pin 2000 pkg-5-strl could not be conducted as the lot number etched on the skull pin does not match supplier ((b)(4)) records as it is an invalid lot number. Therefore, without the lot numbers, a review of the manufacturing records cannot be completed. A 12-month review of the complaint trend analysis for the skull pin 2000 pkg-5-strl was conducted on the specific product code from this complaint as the product family does not exist for this product. It was noted that there were no related complaints associated with the skull pin coming off and sliding; of which there was no harm to the patient but potential may exist if the fault were to recur. Review of complaints found no significant trends. The root cause cannot positively be determined. It is inconclusive of how the skull pin has loosened and slided off. No corrective action/preventive action is required as there has been no issue identified in the manufacturing or release of this device, and there have been no systematic trends. Therefore, this complaint will be closed with no further action required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526439-2014-10544 |
| MDR Report Key | 3575961 |
| Report Source | 01,05,07 |
| Date Received | 2014-01-15 |
| Date of Report | 2013-12-24 |
| Date of Event | 2013-12-24 |
| Date Facility Aware | 2013-12-24 |
| Date Mfgr Received | 2014-03-11 |
| Date Added to Maude | 2014-01-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | ANITA BARNICK |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283583 |
| Manufacturer G1 | DEPUY SYNTHES SPINE |
| 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 | SKULL PIN 2000 PKG-5-STRL |
| Generic Name | COMPONENT, TRACTION, INVASIVE |
| Product Code | JEC |
| Date Received | 2014-01-15 |
| Returned To Mfg | 2014-01-27 |
| Catalog Number | AC020 |
| Lot Number | 16488 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 3 | 2014-01-15 |