FDA Adverse Event
Malfunction
Summary report: N
OIC PEEK SIZE 10 MM - 0DEG
MDR report key: 1841402
·
Received September 7, 2010
Report
- Report Number
- 9617544-2010-00327
- Event Type
- Malfunction
- Date Received
- September 7, 2010
- Date of Event
- July 9, 2010
- Report Date
- July 13, 2010
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- MAX
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
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 ENGINEERING EVAL.
Description of Event or Problem · 1
BEFORE ONE OF OUR DEALER WAS BRINGING THE IMPLANTS TO THE HOSPITAL, THE DEALER FOUND THAT THE HOLE FOR THE MARKER PIN OF THE TWO OIC PEEK CAGES WERE NOT OPEN ALL THE WAY THROUGH THE CAGE. SHOULD THE MARKER PIN HOLE BE OPEN FOR ALL THE SIZES OF THE CAGES? PLEASE LET US KNOW WHETHER THIS WOULD BE A PROBLEM AND WHETHER IT IS WITHIN THE SPECIFICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OIC PEEK SIZE 10 MM - 0DEG | IMPLANT | MAX | STRYKER SPINE BORDEAUX | NA | 51036 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |