FDA Adverse Event
Malfunction
Summary report: N
ALTA MALLET NO REPLACEMENT
MDR report key: 1837776
·
Received September 14, 2010
Report
- Report Number
- 8031020-2010-00116
- Event Type
- Malfunction
- Date Received
- September 14, 2010
- Date of Event
- August 27, 2010
- Report Date
- August 30, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, DURING A THA, WHEN THE SURGEON WAS HITTING SOMETHING WITH THE PLASTIC SIDE OF ALTA MALLET, THE PLASTIC BROKE. SOME SMALL FRAGMENTS OF THE PLASTIC MAY BE IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALTA MALLET NO REPLACEMENT | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS SELZACH | NA | S303740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other |