FDA Adverse Event
Malfunction
Summary report: N
XIA 3 TITANIUM BLOCKER
MDR report key: 2121761
·
Received May 20, 2011
Report
- Report Number
- 9617544-2011-00180
- Event Type
- Malfunction
- Date Received
- May 20, 2011
- Date of Event
- March 30, 2011
- Report Date
- April 26, 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
- SP
- 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 WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.
Description of Event or Problem · 1
OUR CUSTOMER HAS REPORTED TO US VIA SALES REP THAT DURING THE SURGERY ((B)(6) 2011), A XIA 3 TITANIUM BLOCKER-REF: (B)(4)- BREAKS (RADIAL CRACK). THE DYNAMOMETRIC SCREWDRIVER WAS USED AND THE ITEM BREAKS BEFORE THE PRESSURE INDICATED BY THE MANUFACTURER. THE SURGEON COULD NOT RETRIEVE THE PRODUCT, REMAINING IN HIS POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA 3 TITANIUM BLOCKER | IMPLANT | NKB | STRYKER SPINE BORDEAUX | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |