MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-02-05 for MOUNTAINEER 3.5 DIAMETER SCREW UNK ? MOUNTAINEER 3.5 DIAMETER manufactured by Depuy Synthes Spine.
[37610529]
A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device implanted.
Patient Sequence No: 1, Text Type: N, H10
[37610530]
Patient arrived at (b)(6) clinic and during standard post operative follow-up, it was discovered that he had a broken c3 mountaineer screw (3. 5 diameter). At this time no indication was made of a traumatic event which could have caused the fracture. The patient reported doing well after the initial operation to treat cervical disc degeneration with posterior mountaineer fixation from c3-t2. The patient did not have any neurologic or functional deficits from the fractured screw. The surgeon decided to place the patient in a miami-j collar and follow him closely. No planned reoperation at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2016-10111 |
| MDR Report Key | 5413904 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-02-05 |
| Date of Report | 2016-01-11 |
| Date Mfgr Received | 2016-01-11 |
| Date Added to Maude | 2016-02-05 |
| 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 | MICHAEL JACENE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5089776485 |
| 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 | MOUNTAINEER 3.5 DIAMETER SCREW |
| Generic Name | UNKNOWN |
| Product Code | NQW |
| Date Received | 2016-02-05 |
| Catalog Number | UNK ? MOUNTAINEER 3.5 DIAMETER |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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. Required No Informationntervention | 2016-02-05 |