FDA Adverse Event
Malfunction
Summary report: N
#9 FEMORAL CUTTING GUIDE ASSY
MDR report key: 1621860
·
Received February 5, 2010
Report
- Report Number
- 2249697-2009-00951
- Event Type
- Malfunction
- Date Received
- February 5, 2010
- Date of Event
- June 28, 2007
- Report Date
- February 5, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS
- Product Code
- LXH
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS PART OF THE QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORP CONDUCTED A 2 YR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (4) 2006 TO (B) (4) 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 117 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. THE CUSTOMER REPORTED VIA THE TM THAT THE CUTTING GUIDE BROKE DURING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | #9 FEMORAL CUTTING GUIDE ASSY | INSTRUMENTS | LXH | STRYKER ORTHOPAEDICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |