BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA BLOCKER

    MDR report key: 2990619 · Received March 5, 2013

    Report

    Report Number
    3005525032-2013-00015
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    KWP
    PMA / PMN Number
    K060361
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE BLOCKER WAS REPORTED TO HAVE DISLODGED FROM THE HARDWARE CONSTRUCT AND THE PATIENT WAS REVISED TO TIGHTEN THE BLOCKER WITH A XIA CUSTOM TORQUE. NO ADVERSE CONSEQUENCES BESIDES THIS REVISION WERE REPORTED. THE BLOCKER WON¿T BE RETURNED AND THE BATCH NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE EVENT AS REPORTED COULD NOT BE EVALUATED AND THE INVESTIGATION WAS THEREFORE LIMITED AND COULD NOT BE COMPLETED. NO INSPECTION OF THE PRODUCTS COULD BE PERFORMED SO AS TO DETERMINE WHETHER THE RECOMMENDED TORQUE WAS EFFECTIVELY APPLIED BY EXAMINATION OF THE POTENTIAL DEFORMATION OF THE BLOCKER. NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. ACCORDING TO THE COMMENT IN THE COMPLIANT, THE TORQUE WRENCH USED WAS NOT MANUFACTURED BY STRYKER. IN SUCH CASE IT CAN BE ASSUMED THAT THE FINAL TIGHTENING WAS NOT PROPERLY PERFORMED. ADDITIONALLY THIS WOULD BE A DEVIATION FROM INSTRUCTION FOR USE OF THE DEVICE. "LOOSENING OF SPINAL FIXATION IMPLANTS CAN OCCUR. EARLY MECHANICAL LOOSENING MAY RESULT FROM INADEQUATE INITIAL FIXATION, LATENT INFECTION, PREMATURE LOADING OF THE PROSTHESIS OR TRAUMA. CONCLUSION: WHILE IT CAN BE ASSUMED THAT THE FINAL TIGHTENING WAS NOT PROPERLY PERFORMED, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND THE COMPLAINT CONDITION REMAINS UNKNOWN. NO PRODUCT RETURN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "BLOCKER OFF HARDWARE CONSTRUCT. REVISED TO INSERT AND TIGHTEN BLOCKER WITH XIA CUSTOM TORQUE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "BLOCKER OFF HARDWARE CONSTRUCT. REVISED TO INSERT AND TIGHTEN BLOCKER WITH XIA CUSTOM TORQUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93908 XIA BLOCKER SPINAL IMPLANT BLOCKER KWP STRYKER SPINE-SWITZERLAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R