FDA Adverse Event
Injury
Summary report: N
LUMBAR SCREW 6,7 X 40 MM + BALL RING
MDR report key: 1970260
·
Received January 14, 2011
Report
- Report Number
- 9617544-2011-00011
- Event Type
- Injury
- Date Received
- January 14, 2011
- Date of Event
- September 27, 2010
- Report Date
- December 14, 2010
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- MNH
- PMA / PMN Number
- K010845
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.
Description of Event or Problem · 1
MRS (B)(6), EMPLOYEE FROM THE DISTRIBUTOR, REPORTED THAT 2 SCREWS BROKE ON (B)(6) 2010 WHEN THE PATIENT WAS TAKING HIS SHOWER AND FELL DOWN. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2009 FOR AN ARTHRODESIS. A REVISION WAS PERFORMED ON (B)(6) 2010 BECAUSE OF SIGNIFICANT SECONDARY PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMBAR SCREW 6,7 X 40 MM + BALL RING | IMPLANT | MNH | STRYKER SPINE BORDEAUX | NA | 092720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |