FDA Adverse Event
Malfunction
Summary report: N
XIA BLOCKER
MDR report key: 1041354
·
Received May 6, 2008
Report
- Report Number
- 9617544-2008-00040
- Event Type
- Malfunction
- Date Received
- May 6, 2008
- Date of Event
- April 10, 2008
- Report Date
- April 16, 2008
- Manufacturer
- STRYKER SPINE BORDEAUX
- Product Code
- KWP
- PMA / PMN Number
- K060361
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SURGERY PROCEDURE, THE SURGEON TIGHTENED THE BLOCKER WITH THE UNIVERSAL TIGHTENER ACCORDING THE OP TECHNIQUE AND FIXED THE BLOCKER WITH A TORQUE WRENCH AND A TORQUE KEY. DURING THIS THE BLOCKER BROKE OFF. TO COMPLETE THE SURGERY, THE SURGEON HAD TO CHANGE THE ROD AND THE BLOCKER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XIA BLOCKER | IMPLANT | KWP | STRYKER SPINE BORDEAUX | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |