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 2015-10-30 for IMPLANT, FIXATION DEVICE, SPINAL manufactured by Synthes Usa.
[29975377]
Device was used for treatment, not diagnosis. This report is for unknown spinal device(s). (b)(4). The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided. 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
[29975378]
This report is being filed after the subsequent review of the following literature article, sekhon, l. H. S. (2005). Posterior cervical lateral mass screw fixation analysis of 1026 consecutive screws in 143 patients. J spinal disorder tech(2005). Australia. This study evaluates the results and complications of 1026 consecutive lateral mass screws inserted in 143 patients by a single surgeon. Over a 50-month period, a total of 1026 lateral mass screws were placed in 143 patients ages 12? 96 years (56 females and 87 males), with these records retrospectively reviewed. A variety of different implants were used including synthes' and competitors' devices. There is no correlation between reported complications and synthes/competitor's devices. This report is for the following complications: dural tears(3), deep infection, c5 root injury(1), adjacent segment requiring surgery(1), hematoma requiring evacuation(1). This is report #2 of 3 for (b)(4). This report is for a variety of different implants including synthes' and competitors' devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2015-16933 |
| MDR Report Key | 5191440 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-10-30 |
| Date of Report | 2015-10-14 |
| Date Mfgr Received | 2015-10-14 |
| Date Added to Maude | 2015-10-30 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | IMPLANT, FIXATION DEVICE, SPINAL |
| Product Code | JDN |
| Date Received | 2015-10-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-30 |