FDA Adverse Event
Malfunction
Summary report: N
MRH AXLE
MDR report key: 1629258
·
Received February 5, 2010
Report
- Report Number
- 9610726-2009-00282
- Event Type
- Malfunction
- Date Received
- February 5, 2010
- Date of Event
- November 26, 2007
- Report Date
- February 5, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- KRO
- PMA / PMN Number
- K994207
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO (B) (6) 2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION # (B) (4). THERE IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (POTENTIAL MANUFACTURING ERROR) AND PRODUCT CODE KRO.
Description of Event or Problem · 1
POTENTIAL MANUFACTURING ERROR. IT WAS REPORTED THAT, "PIN SEEMS TO BE PROTRUDING MEDIALLY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MRH AXLE | IMPLANT | KRO | STRYKER ORTHOPAEDICS LIMERICK | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |