FDA Adverse Event
Injury
Summary report: N
LUMBAR SCREW 6.7 X 40 MM + BALL RING
MDR report key: 726665
·
Received June 15, 2006
Report
- Report Number
- 9617544-2006-00040
- Event Type
- Injury
- Date Received
- June 15, 2006
- Date of Event
- July 14, 2004
- Report Date
- May 18, 2006
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- HWC
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD: NEITHER THE DEVICE OR X-RAYS WERE AVAILABLE FOR EVALUATION. NOT DETERMINED DUE TO INSUFFICIENT INFORMATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPERATION WITH STRYKER PRODUCT IN 2003. 10 MONTHS AFTER THE SURGERY, HE TOOK AN X-RAY, AND IT WAS FOUND THAT THE SCREW HAD BROKEN. IN 2005, THE PRODUCT WAS EXPLANTED FROM THE BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMBAR SCREW 6.7 X 40 MM + BALL RING | IMPLANT | HWC | STRYKER SPINE BORDEAUX | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Required Intervention |