FDA Adverse Event
Malfunction
Summary report: N
DURACON WEDGE CLAMP KIT
MDR report key: 1629235
·
Received February 5, 2010
Report
- Report Number
- 9610726-2009-00272
- Event Type
- Malfunction
- Date Received
- February 5, 2010
- Date of Event
- August 23, 2006
- Report Date
- February 5, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- LXH
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, 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 ARE 2 EVENTS ASSOCIATED WITH THIS EVENT TYPE (DEVICE BROKE OR DISASSEMBLED DURING USE) AND PRODUCT CODE LXH.
Description of Event or Problem · 1
DEVICE BROKE OR DISASSEMBLED DURING USE. IT WAS REPORTED "BLACK PLASTIC PIECE BROKE AND WAS LOST."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURACON WEDGE CLAMP KIT | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS LIMERICK | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |