FDA Adverse Event
Malfunction
Summary report: N
VERTE-STACK SPINAL SYSTEM
MDR report key: 1083818
·
Received July 25, 2008
Report
- Report Number
- 1030489-2008-00390
- Event Type
- Malfunction
- Date Received
- July 25, 2008
- Date of Event
- July 30, 2007
- Report Date
- August 22, 2007
- Manufacturer
- SOFAMOR DANEK DEGGENDORF GMBH
- Product Code
- MQP
- PMA / PMN Number
- K041556
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS NOT RECEIVED FOR EVALUATION. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT UNDERWENT A SPINAL PROCEDURE USING INTERBODY DEVICE. THE DEVICE WAS BROKEN DURING IMPACTION. THE BROKEN DEVICE WAS REPLACED. NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERTE-STACK SPINAL SYSTEM | VB REPLACEMENT | MQP | SOFAMOR DANEK DEGGENDORF GMBH | NA | MF25 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |