MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-11-06 for CHISEL 10MM PDL322 manufactured by Synthes (usa).
[1302241]
Surgeon alleges potential chisel involvement related to vertebral body fractures noted post pdl implant. There is no way of knowing which devices were used in which procedures but all 3 were used at the same facility with the same surgeon. This is related to events previously reported to the fda under pdl implant part numbers. This is the first of three reports.
Patient Sequence No: 1, Text Type: D, B5
[8359497]
This device is not single use and was used in multiple disc arthroplasty procedures. The surgeon can not determine which chisels were used in which procedures. Device is an instrument and is not implanted. Date of manufacture can not be determined. Investigation could not be completed, no conclusion could be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2009-00204 |
| MDR Report Key | 1525383 |
| Report Source | 05,07 |
| Date Received | 2009-11-06 |
| Date of Report | 2009-10-05 |
| Date Mfgr Received | 2009-10-05 |
| Date Added to Maude | 2009-11-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TRISH MCCARRON |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES (USA) |
| Manufacturer Street | 1101 SYNTHES AVE. |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHISEL 10MM |
| Generic Name | CHISELS |
| Product Code | EML |
| Date Received | 2009-11-06 |
| Model Number | NA |
| Catalog Number | PDL322 |
| Lot Number | A7OA11 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-11-06 |