FDA Adverse Event
Malfunction
Summary report: N
RPS SELF HOLDING HEXAG SCREWDRIVER 4.5 MM
MDR report key: 1640979
·
Received February 5, 2010
Report
- Report Number
- 9617544-2009-00568
- Event Type
- Malfunction
- Date Received
- February 5, 2010
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4). AS PART OF A QUALITY SYSTEM IMPROVEMENT PLANT, STRYKER CORP CONDUCTED A 2 YR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO (B) (6) 2008 WERE WITHIN SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION #(B) (4). THERE ARE 286 REPORTABLE EVENTS ASSOCIATED WITH THIS EVENT TYPE (MALFUNCTION - DOES NOT PERFORM AS INTENDED) AND PRODUCT CODE LXH.
Description of Event or Problem · 1
THE BALL OF HEXAGONAL TIP OF DIAPASON SELF HOLDING 4.5MM SCREWDRIVER HAS NOT BEEN WORKING. SO THE SCREWDRIVER CANNOT HOLD BLOCKER TIGHTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RPS SELF HOLDING HEXAG SCREWDRIVER 4.5 MM | NA | LXH | STRYKER SPINE BORDEAUX | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |