MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-28 for COONRAD/MORREY PIVOT PIN 32-8106-000-10 manufactured by Zimmer, Inc..
[20061726]
C-ring became loose allowing the pivot pin to back out. Surgeon also replaced the ulnar portion to the elbow (32-8105-001).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1826933-1995-00004 |
| MDR Report Key | 26315 |
| Date Received | 1995-08-28 |
| Date of Report | 1995-08-25 |
| Date of Event | 1995-08-24 |
| Date Facility Aware | 1995-08-24 |
| Report Date | 1995-08-25 |
| Date Reported to FDA | 1995-08-25 |
| Date Reported to Mfgr | 1995-08-25 |
| Date Added to Maude | 1995-10-02 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COONRAD/MORREY PIVOT PIN |
| Generic Name | PIVOT PIN |
| Product Code | KWJ |
| Date Received | 1995-08-28 |
| Model Number | NA |
| Catalog Number | 32-8106-000-10 |
| Lot Number | 33774200 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 26987 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | 1777 W CTR ST WARSAW IN 46580 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-08-28 |