FDA Adverse Event
Malfunction
Summary report: N
AVS UNILIF SPACER 9 X 30 X 0DEG - 11MM
MDR report key: 3940233
·
Received July 17, 2014
Report
- Report Number
- 0009617544-2014-00313
- Event Type
- Malfunction
- Date Received
- July 17, 2014
- Date of Event
- June 23, 2014
- Report Date
- June 23, 2014
- Manufacturer
- STRYKER SPINE-FRANCE
- Product Code
- MAX
- PMA / PMN Number
- K080758
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: THE FRACTURE WAS CONFIRMED BY VISUAL INSPECTION OF THE RETURNED DEVICE. THE DEVICE IS FRACTURED INTO 2 SEPARATE PIECES. NO RELEVANT ISSUES WERE FOUND IN THE MANUFACTURING RECORDS OF THE DEVICE LOT THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. IT WAS REPORTED THAT THE DISC SPACE WAS TIGHT. CONCLUSION: THE PLAUSIBLE ROOT CAUSE OF THE REPORTED EVENT IS INADEQUATE DISC SPACE PREPARATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UNILIF SPACER BROKE WHEN MALLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UNILIF SPACER BROKE WHEN MALLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 418363 | AVS UNILIF SPACER 9 X 30 X 0DEG - 11MM | IMPLANT-SPACER | MAX | STRYKER SPINE-FRANCE | DON'T KNOW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |