FDA Adverse Event
Malfunction
Summary report: N
MRH TIB BP PEG EX SML
MDR report key: 2191407
·
Received July 28, 2011
Report
- Report Number
- 9610726-2011-00265
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- June 30, 2011
- Report Date
- July 7, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- KRO
- PMA / PMN Number
- K994207
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "DURING THE FINAL REDUCTION, THE SURGEON FELT THAT THE BASEPLATE (20MM) WAS THICKER THAN THE TRIAL BASEPLATE (20MM). THEREFORE, HE IMPLANTED A 16MM INSERT INSTEAD OF IT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MRH TIB BP PEG EX SML | IMPLANT | KRO | STRYKER ORTHOPAEDICS LIMERICK | NA | SXKLM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |