FDA Adverse Event
Other
Summary report: N
VERTEVIEW CERVICAL PLATING SYSTEM
MDR report key: 2425253
·
Received January 16, 2012
Report
- Report Number
- 3003855635-2012-00001
- Event Type
- Other
- Date Received
- January 16, 2012
- Date of Event
- December 16, 2011
- Report Date
- January 16, 2011
- Manufacturer
- ATLAS SPINE INC.
- Product Code
- KWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
RECEIVED NOTICE THAT DURING A 10 DAY POST-OP VISIT X-RAYS INDICATE THE CERVICAL PLATE WAS PULLING OUT. X-RAYS OBTAINED IMMEDIATE POST-OP, 10 DAYS POST-OP, 35 DAYS POST-OP AND 35 PLUS DAYS POST-OP INDICATE THAT C-7 VERTEBRAE WAS DETERIORATING. SURGEON INDICATED THAT THE PATIENT WAS NON-OSTEOPOROTIC. X-RAYS WERE REVIEWED BY ANOTHER SURGEON AND IT WAS DETERMINED THAT THE C-7 ENDPLATE MUST HAVE BEEN COMPROMISED/DAMAGED AND WAS DETERIORATING THUS CAUSING THE SCREW PURCHASE REDUCTION. ATTENDING SURGEON INDICATED NO REVISION SURGERY INTENDED AT THIS TIME, PATIENT WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERTEVIEW CERVICAL PLATING SYSTEM | NONE | KWQ | ATLAS SPINE INC. | 70002-040 | 01019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |