FDA Adverse Event
Injury
Summary report: N
OIC PEEK SIZE 9 MM - 4DEG - L20 MM
MDR report key: 2251347
·
Received September 13, 2011
Report
- Report Number
- 9617544-2011-00310
- Event Type
- Injury
- Date Received
- September 13, 2011
- Date of Event
- August 17, 2011
- Report Date
- August 17, 2011
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- MAX
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
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 AN ENGINEERING EVAL.
Description of Event or Problem · 1
IT WAS RE-PORTED THAT OIC PEEK WAS IMPLANTED IN (B)(6) 2011. THE PT CAME TO THE HOSPITAL AND IT WAS NOTICED THAT THE CAGE WAS CAME OFF ON (B)(6) 2011. THE REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OIC PEEK SIZE 9 MM - 4DEG - L20 MM | IMPLANT | MAX | STRYKER SPINE BORDEAUX | NA | 60766 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| R |