FDA Adverse Event
Malfunction
Summary report: N
ALTA CHANNEL PLT 151MM
MDR report key: 66916
·
Received January 31, 1997
Report
- Report Number
- 2219689-1997-00056
- Event Type
- Malfunction
- Date Received
- January 31, 1997
- Date of Event
- December 31, 1996
- Manufacturer
- HOWMEDICA, INC.
- Product Code
- HRS
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
SUMMARY OF EVALUATION: SEM ANALYSIS SHOWED THAT THE RETURNED ALTA 6 HOLE CHANNEL PLATE BROKE IN FATIGUE. SEM ANALYSIS RESULTS SUGGEST THAT THIS EVENT WOULD NOT BE ASSOCIATED WITH THE DEVICE. HOWEVER, THERE IS INSUFFICIENT INFO PROVIDED IN THE PRODUCT COMPLAINT RPT TO DETERMINE THE CAUSE FOR THE FRACTURE OF THE RETURNED ALTA CHANNEL PLATE IN FATIGUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALTA CHANNEL PLT 151MM Implant | IMPLANT | HRS | HOWMEDICA, INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |