MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-11-13 for PATHFINDER/DSS GENERIC 1100 PATHFINDER-DSS manufactured by Zimmer Spine.
[1116856]
In 2009, the sales representative reported that there was a revision surgery for an unknown reason. No sales representatives were in surgical suite. When the sales representative retrieved the instruments, it was identified that the tips of the drivers were twisted. There is no further information available.
Patient Sequence No: 1, Text Type: D, B5
[8306568]
No device will be returned. This medwatch was implemented to report an adverse event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649384-2009-00353 |
| MDR Report Key | 1531138 |
| Report Source | 07 |
| Date Received | 2009-11-13 |
| Date of Report | 2009-11-13 |
| Date of Event | 2009-10-15 |
| Date Mfgr Received | 2009-10-16 |
| Date Added to Maude | 2009-11-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH CLOSNER, RN, BSN, SPECIAL |
| Manufacturer Street | 5301 RIATA PARK COURT, BLDG. F |
| Manufacturer City | AUSTIN TX 78727 |
| Manufacturer Country | US |
| Manufacturer Postal | 78727 |
| Manufacturer Phone | 5125331981 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATHFINDER/DSS GENERIC |
| Generic Name | PATHFINDER |
| Product Code | GFC |
| Date Received | 2009-11-13 |
| Catalog Number | 1100 PATHFINDER-DSS |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SPINE |
| Manufacturer Address | AUSTIN TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-11-13 |