BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 55 MM

    MDR report key: 2142703 · Received April 29, 2011

    Report

    Report Number
    9617544-2011-00140
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 25, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K071373
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, COMPLAINT HIST. ANALYSIS, MFG RECORD REV AND RISK ASSESS REVIEW. RESULT: VISUAL INSPECTION CONFIRMS REPORTED FAILURE. COMPLAINT HISTORY ANALYSIS- 22 COMPLAINTS FOR POLYAXIAL SCREW TULIP DISENGAGEMENT. NONE WITH SAME SERIAL NUMBERS. MANUFACTURING RECORD REVIEW - MFG RECORDS WERE REVIEWED BUT NO RELEVANT DEVIATIONS WERE REPORTED. RISK ASSESSMENT REVIEW - PER THIS COMPLAINT, REVISION SURGERY IMPLIES INCREASED RISK FOR THE PT. CONCLUSIONS: THE EVENT WAS CONFIRMED BY VISUAL INSPECTION. THERE WAS LIGHT CROSS-THREADING WITH THE BLOCKER. HEX OF THE BLOCKER IS DAMAGED, NUMEROUS SCRATCHES ARE VISIBLE. ONE ROD IS BENT COMPARED TO THE STANDARD. IT IS NOT KNOWN IF BENDING WAS DONE BY THE SURGEONS OR NOT. PER (B)(4) AND (B)(4) LAB, TULIP DISENGAGEMENT FROM BONE SCREW IS OFTEN THE RESULT OF EXCESSIVE TORQUE AND OVERLOADING AND IMPLANTING THE SCREW AT THE MAXIMUM ANGLE. THE PRINCIPAL CAUSE OF THE REPORTED EVENT IS RELATED TO USER TECHNIQUE AND NOT TO MANUFACTURING OR METALLURGIC PROBLEM.

    Description of Event or Problem · 1

    DR. (B)(6) AND DR. (B)(6) REPORT VIA OUR SALES REP, (B)(4), THAT THEY RECOGNIZED A NEW DAYS AFTER IMPLANTATION, WHICH WAS ON (B)(6), ON A CT THAT THE HEADS LOOSENED FROM THE SCREWS. A REVISION TOOK PLACE ON (B)(6) AND XIA 1 SCREWS, 8.5MM, WERE USED AS EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 55 MM IMPLANT NKB STRYKER SPINE BORDEAUX NA B04999

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O| R 2 BLOCKERS (P/N 48230000, S/N (B)(4))| 2 RODS (P/N 48238070, S/N (B)(4))| REPORT FILED 9617544-2011-00141)| SCREW (P/N 482317550, S/N (B)(4) - SEPARATE