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 |