FDA Adverse Event
Malfunction
Summary report: N
XIA 3 TITANIUM BLOCKER
MDR report key: 4212977
·
Received October 30, 2014
Report
- Report Number
- 3005525032-2014-00113
- Event Type
- Malfunction
- Date Received
- October 30, 2014
- Date of Event
- October 1, 2014
- Report Date
- October 2, 2014
- Manufacturer
- STRYKER SPINE-SWITZERLAND
- Product Code
- NKB
- PMA / PMN Number
- K113666
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METHOD: DEVICE HISTORY REVIEW AND DEVICE INSPECTION.RESULTS: VISUAL INSPECTION CONCLUDED THE BLOCKERS THREAD WAS CONFIRMED TO BE SHEARED. IN ADDITION, CROSS-THREADING IS ALSO VISIBLE ON THE THREADS. FUNCTIONAL INDICATED THE BLOCKER IS NO LONGER FUNCTIONAL DUE TO THE FRACTURE. CONCLUSION: A PLAUSIBLE ROOT CAUSE IS EXCESSIVE TORSIONAL FORCE AND MISALIGNMENT OF THE BLOCKER. THE BLOCKER SHOWS SIGNS OF CROSS-THREADING. EXCESSIVE TORSIONAL FORCE WHILE THE THREAD WAS MISALIGNED MAY HAVE CAUSED PART OF THE THREAD TO SHEAR OFF.
Description of Event or Problem · 1
IT WAS REPORTED THAT SURGEON WAS FINAL TIGHTENING BLOCKER ON HOOK AND BLOCKER SHEARED.
Description of Event or Problem · 1
IT WAS REPORTED THAT SURGEON WAS FINAL TIGHTENING BLOCKER ON HOOK AND BLOCKER SHEARED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 695029 | XIA 3 TITANIUM BLOCKER | IMPLANT-BLOCKER | NKB | STRYKER SPINE-SWITZERLAND | G8U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |