BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA BLOCKER

    MDR report key: 3182979 · Received June 21, 2013

    Report

    Report Number
    3005525032-2013-00055
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    KWP
    PMA / PMN Number
    K982494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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: COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE XIA BLOCKER DISENGAGED FROM THE XIA SCREW. THIS EVENT WAS RECOGNIZED POST-OP AND REQUIRED A REVISION SURGERY TO REPLACE BOTH THE SCREW AND BLOCKER. NO MANUFACTURING RECORDS COULD BE REVIEWED BECAUSE NO LOT # WAS PROVIDED. THE MOST LIKELY CAUSE FOR THIS EVENT IS IMPROPER FINAL TIGHTENING OF THE BLOCKER DURING SURGERY. THE SURGICAL TECHNIQUE STATES THAT THE TORQUE WRENCH MUST BE USED TO PROVIDE 12NM OF TORQUE ON THE BLOCKER IN ORDER TO PROPERLY TIGHTEN IT. HOWEVER, WE CANNOT CONCLUSIVELY DETERMINE THIS AS THE CAUSE, SINCE THE PRODUCT WAS NOT RETURNED FOR FURTHER EVALUATION. CONCLUSION: THE MOST LIKELY CAUSE FOR THIS EVENT IS IMPROPER FINAL TIGHTENING OF THE BLOCKER DURING SURGERY, HOWEVER, NO PRODUCT HAS BEEN RECEIVED FOR EVALUATION. THEREFORE, THE EXACT CAUSE COULD NOT BE DETERMINED AND IS LIKELY MULTIFACTORIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "REVISION SURGERY FOR A LOOSE XIA BLOCKER-ROD WAS PISTONING. REPLACED WITH LARGER DIAMETER SCREW AND NEW BLOCKER. REVISING SURGERY THAT WAS DONE (B)(6) 2013."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "REVISION SURGERY FOR A LOOSE XIA BLOCKER-ROD WAS PISTONING. REPLACED WITH LARGER DIAMETER SCREW AND NEW BLOCKER. REVISING SURGERY THAT WAS DONE (B)(6) 2013."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283614 XIA BLOCKER IMPLANT KWP STRYKER SPINE-SWITZERLAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R