FDA Adverse Event
Injury
Summary report: N
XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6
MDR report key: 2574066
·
Received May 2, 2012
Report
- Report Number
- 9617544-2012-00177
- Event Type
- Injury
- Date Received
- May 2, 2012
- Date of Event
- April 5, 2012
- Report Date
- April 5, 2012
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- NXB
- PMA / PMN Number
- K061854
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED, AND IF MADE AVAILABLE, THIS WILL BE REPORTED AS SUPPLEMENTAL. METHOD, RESULT AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVAL.
Description of Event or Problem · 1
DR. (B)(6) REPORTED TO (B)(6): DR. (B)(4) (SPINE SALES MGR) THAT THE PT IS A CASE OF CONGENITAL SPONDYLOLISTHESIS. THE DR HAS DONE A SCREW FIXATION AND LISTHESIS REDUCTION WITH 4 SCREWS. AFTER THE PT FEELS PAIN AND RADICULOPATHY IS LOW BACK AND HIS LOWER EXTREMITY. THE DR ASKS FOR A CONTROL X-RAY WHICH SHOWS 3 BROKEN SCREWS AND AN ABOUT TO LOOSE BLOCKER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6 | IMPLANT | NXB | STRYKER SPINE BORDEAUX | NA | TBC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Hospitalization| R |