FDA Adverse Event
Injury
Summary report: N
OPTERYX
MDR report key: 1565675
·
Received December 23, 2009
Report
- Report Number
- 3004719693-2009-00004
- Event Type
- Injury
- Date Received
- December 23, 2009
- Date of Event
- December 2, 2009
- Report Date
- December 22, 2009
- Manufacturer
- INNOVASIS, INC.
- Product Code
- KWQ
- PMA / PMN Number
- K061147
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L LOT NUMBER 0801.
Description of Event or Problem · 1
IN 2009, OUR DISTRIBUTOR REPORTED THAT HE WAS SENDING 4 BROKEN SCREWS, THREE UNBROKEN SCREWS AND A CERVICAL PLATE THAT HAD BEEN REMOVED FROM A PT. REVISION SURGERY HAD APPARENTLY BEEN PERFORMED IN MID NOVEMBER AFTER PT REPORTED NECK PAIN FOR SEVERAL WEEKS AFTER FALLING, APPROX EARLY OCTOBER. ORIGINAL FUSION SURGERY HAD BEEN EIGHT MONTHS AGO. X-RAY PRIOR TO REVISION SURGERY WAS RECEIVED AT INNOVASIS DAY OF REPORT. THIS SHOWED THE CERVICAL PLATE WITH BROKEN SCREWS AND THE LOWER PORTION OF THE PLATE SEPARATED FROM THE VERTEBRAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPTERYX | CERVICAL PLATE | KWQ | INNOVASIS, INC. | 13MM VARIABLE X 4 | 0704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention |