FDA Adverse Event
Malfunction
Summary report: N
VLIFT CAGE DIAM 18 X 25MM
MDR report key: 2871706
·
Received December 11, 2012
Report
- Report Number
- 9617544-2012-00556
- Event Type
- Malfunction
- Date Received
- December 11, 2012
- Date of Event
- November 13, 2012
- Report Date
- November 13, 2012
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- MQP
- PMA / PMN Number
- K060506
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE THIS WILL BE REPORTED AS SUPPLEMENTAL. METHOD, RESULT AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "WHEN THE SET WAS OPENED FOR RESTOCKING AND REVIEW IT WAS FOUND THAT THE 18X25 VLIFT CAGE LOCKING SCREW APPEARED TO BE DAMAGED BEYOND REPAIR-CAUSE UNKNOWN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VLIFT CAGE DIAM 18 X 25MM | IMPLANT | MQP | STRYKER SPINE BORDEAUX | NA | 121494 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |