FDA Adverse Event
Malfunction
Summary report: N
VBOSS 20MM LARGE OVAL ENDCAP
MDR report key: 2013483
·
Received February 3, 2011
Report
- Report Number
- 9617544-2011-00044
- Event Type
- Malfunction
- Date Received
- February 3, 2011
- Date of Event
- January 3, 2011
- Report Date
- January 19, 2011
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- MQP
- PMA / PMN Number
- K033837
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT "WHILE IMPACTING THE END CAPS FOR A VBOSS CAGE, THE ENDCAPS BROKE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VBOSS 20MM LARGE OVAL ENDCAP | IMPLANT | MQP | STRYKER SPINE BORDEAUX | NA | 043303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |