FDA Adverse Event
Other
Summary report: N
OIC PEEK SIZE 11 MM - 8DEG
MDR report key: 1416581
·
Received April 3, 2009
Report
- Report Number
- 9617544-2009-00094
- Event Type
- Other
- Date Received
- April 3, 2009
- Date of Event
- January 9, 2009
- Report Date
- March 21, 2009
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- KWQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT IS BEING RETURNED TO MANUFACTURER. INVESTIGATION IS UNDERWAY. ADDITIONAL INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
CHINA MARKETING RECEIVED SOME OIC CAGE WITH TANTALUM. BUT THE PART NUMBER 6731108 (LOT NO. 48500) IS WRONG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OIC PEEK SIZE 11 MM - 8DEG | IMPLANT | KWQ | STRYKER SPINE BORDEAUX | 48500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |