FDA Adverse Event
Malfunction
Summary report: N
XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 50 MM
MDR report key: 2210270
·
Received August 8, 2011
Report
- Report Number
- 9617544-2011-00274
- Event Type
- Malfunction
- Date Received
- August 8, 2011
- Date of Event
- July 11, 2011
- Report Date
- July 12, 2011
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- NKB
- PMA / PMN Number
- K071373
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NURSE
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 WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.
Description of Event or Problem · 1
JANINE NURSE OF THE HOSP REPORTED TO OUR SALES REP MATHIAS KLOPF THAT SHE WAS OBSERVING A SURGERY PROCEDURE. DURING THIS SHE OBSERVED THAT WHILST THE SURGEON IMPLANT, THE TIP OF THE SCREW WAS SOLVED. THERE WAS A DELAY OF 5 MIN. THE SURGERY WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 50 MM | IMPLANT | NKB | STRYKER SPINE BORDEAUX | NA | B10834 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |