FDA Adverse Event
Malfunction
Summary report: N
XIA BLOCKER
MDR report key: 1111958
·
Received August 11, 2008
Report
- Report Number
- 9617544-2008-00076
- Event Type
- Malfunction
- Date Received
- August 11, 2008
- Date of Event
- July 1, 2008
- Report Date
- July 24, 2008
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- NKB
- PMA / PMN Number
- K060361
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT, TWO MONTHS AFTER THE SURGERY DATE, THE SURGEON DETECTED VIA X-RAY THAT THE REF. (B) (4) (XIA BLOCKER) HAD MOVED FROM THE INITIAL POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA BLOCKER | IMPLANT | NKB | STRYKER SPINE BORDEAUX | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other |