FDA Adverse Event
Injury
Summary report: N
9612771-2006-00030
MDR report key: 771272
·
Received October 6, 2006
Report
- Report Number
- 9612771-2006-00030
- Event Type
- Injury
- Date Received
- October 6, 2006
- Product Code
- KWR
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
AS OF THIS DATE THE DEVICE(S) HAS NOT BEEN RETURNED TO PLUS ORTHOPEDICS. SHOULD EXPLANTED DEVICES BE RETURNED AT SOME POINT IN THE FUTURE, THEY WILL BE FORWARDED FOR A MFR EVAL TO BE PERFORMED. PLUS ORTHOPEDIC HAS REQUESTED OPERATIVE REPORTS, X-RAYS, EXPLANTS, AND DETAILS OF THE REVISION SURGERY (INCLUDING IDENTIFICATION OF THE IMPLANTS REQUIRING REVISION). PLUS HAS NOT YET BEEN INFORMED AS TO WHICH IMPLANTS WERE AFFECTED OR WHICH WERE REMOVED SO PLUS IS UNABLE TO IDENTIFY THE MODEL OR CATALOG NUMBERS FOR THE EVENT REPORT. ALSO, THE REVISION WAS PERFORMED WITH OTHER MFR'S PRODUCTS SO PLUS DOES NOT HAVE ANY RECORDS OR INFO WHICH MAY INDICATE WHAT IMPLANTS WERE REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KWR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |