MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-03-28 for PATHFINDER/DDS GENERIC 1100 PATHFINDER-DSS manufactured by Zimmer Sping.
[2571377]
It was reported that two pathfinder screws were removed from the pt due to being loose. No further information is available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
[9706005]
It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. The batch number is unk and the manufacturing records for the complaint device could not be reviewed. This is the final report that will be submitted associated with this incident and device. No additional action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649384-2012-00033 |
| MDR Report Key | 2512438 |
| Report Source | 01,08 |
| Date Received | 2012-03-28 |
| Date of Report | 2012-02-27 |
| Date of Event | 2012-02-27 |
| Date Mfgr Received | 2012-02-27 |
| Date Added to Maude | 2012-09-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SCOTT LAPOINTE |
| Manufacturer Street | 7375 BUSH LAKE RD |
| Manufacturer City | EDINA MN 55439 |
| Manufacturer Country | US |
| Manufacturer Postal | 55439 |
| Manufacturer Phone | 9528575636 |
| Manufacturer Street | 5301 RIATA PARK COURT BLDG F |
| Manufacturer City | AUSTIN TX 78727 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78727 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATHFINDER/DDS GENERIC |
| Generic Name | PATHFINDER/DSS GENERIC |
| Product Code | GFC |
| Date Received | 2012-03-28 |
| Model Number | 1100 PATHFINDER-DSS |
| Catalog Number | 1100 PATHFINDER-DSS |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SPING |
| Manufacturer Address | 5301 RIATA PARK COURT BLDG. F AUSTIN TX 78727 US 78727 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-28 |