BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA 3 TITANIUM BLOCKER

    MDR report key: 3171152 · Received June 14, 2013

    Report

    Report Number
    3005525032-2013-00050
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    MNH
    PMA / PMN Number
    K071373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL REPORT. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: THE RETURNED BLOCKER IS REPORTED TO BE A XIA 3 TITANIUM BLOCKER, CATALOG # 48230000, LOT # PCF. THE RETURNED BLOCKER WAS EXAMINED UNDER A MICROSCOPE AND NO NONCONFORMITIES WERE OBSERVED. THE BLOCKER DID HAVE SEVERAL SCRATCHES ON THE THREADS WITH A SMALL DEFORMATION NOT CHARACTERISTIC OF A 12 NM TIGHTENING FORCE INDICATING THAT THE SCREW WAS TORQUED TWICE DURING THE INITIAL SURGICAL PROCEDURE. FURTHERMORE THERE WERE TWO INDENTATIONS ON THE SCREW HEAD SIGNIFYING THAT THE SCREW WAS INDEED TORQUED TWICE DURING THE INITIAL SURGICAL PROCEDURE. ADDITIONALLY EVIDENCE OF CROSS THREADING ON THE TULIP WAS VISUALLY NOTICED. MANUFACTURING RECORDS WERE CHECKED AND NO RELEVANT NONCONFORMITIES WERE IDENTIFIED. NO DEVIATIONS OR NON-CONFORMITIES WERE FOUND DURING MANUFACTURING OF THE INVOLVED BLOCKER AND SCREW. CONCLUSION: THE DISENGAGEMENT OF THE BLOCKER FROM THE BONE SCREW TULIP WAS DUE TO OVER TIGHTEN OF THE BLOCKER WHICH CAUSED THE TULIP TO DISENGAGE.

    Description of Event or Problem · 1

    A REVISION SURGERY WAS CONDUCTED BECAUSE A XIA BLOCKER DISLODGED FROM THE TULIP HEAD.

    Description of Event or Problem · 1

    A REVISION SURGERY WAS CONDUCTED BECAUSE A XIA BLOCKER DISLODGED FROM THE TULIP HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271004 XIA 3 TITANIUM BLOCKER IMPLANT MNH STRYKER SPINE-SWITZERLAND PCF

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR