FDA Adverse Event
Malfunction
Summary report: N
OASYS 3.5 X 20MM POLYAXIAL SCREW
MDR report key: 2050005
·
Received March 25, 2011
Report
- Report Number
- 9617544-2011-00117
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Date of Event
- February 28, 2011
- Report Date
- February 28, 2011
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- MNI
- PMA / PMN Number
- K032394
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L 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
DR (B)(6) REPORTS VIA OUR SALES REP THAT DURING SURGERY, BOTH SCREWS WERE PARTLY IMPLANTED, BUT HE WAS NOT ABLE TO FASTEN THEM. HE FURTHERMORE REPORTS THAT HE UNSCREWED BOTH SCREWS AND FINISHED THE SURGERY USING TWO OTHER SCREWS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OASYS 3.5 X 20MM POLYAXIAL SCREW | IMPLANT | MNI | STRYKER SPINE BORDEAUX | NA | 088513 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |