BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVS PL SPACER 8 X 25 X 4 DEG - 8

    MDR report key: 3200964 · Received July 2, 2013

    Report

    Report Number
    0009617544-2013-00251
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    April 30, 2013
    Report Date
    June 5, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MQP
    PMA / PMN Number
    K050624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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: DEVICE HISTORY REVIEW, COMPLAINT HISTORY REVIEW, RISK ASSESSMENT. RESULTS: THE CUSTOMER REPORTED A FRACTURE OF AN AVS PL SPACER. THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE IDENTIFIED. IT IS LIKELY THAT THE USER MAY HAVE EXCESSIVELY IMPACTED THE SPACER WITH THE MALLET DURING INSERTION. NO FURTHER EVALUATION POSSIBLE. CONCLUSION: THE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED DUE TO THE ABSENCE OF THE DEVICE AND LIMITED INFORMATION.

    Description of Event or Problem · 1

    "AS THE SURGEON WAS PLACING PEEK CAGE IN AT LEFT L5-S1 WITH INSERTER AND MALLET, HE NOTED THE PEEK CAGE HAD BROKEN INTO TWO (2) PIECES. BOTH PIECES WERE REMOVED AND NEW PEEK CAGE INSERTED. NO PATIENT HARM." INTENDED PROCEDURE WAS "TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1 USING PEEK CAGES AND VITOSS PUTTY."

    Description of Event or Problem · 1

    "AS THE SURGEON WAS PLACING PEEK CAGE IN AT LEFT L5-S1 WITH INSERTER AND MALLET, HE NOTED THE PEEK CAGE HAD BROKEN INTO TWO (2) PIECES. BOTH PIECES WERE REMOVED AND NEW PEEK CAGE INSERTED. NO PATIENT HARM." INTENDED PROCEDURE WAS "TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1 USING PEEK CAGES AND VITOSS PUTTY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303529 AVS PL SPACER 8 X 25 X 4 DEG - 8 IMPLANT MQP STRYKER SPINE-FRANCE 66320

    Patients

    Seq Age Sex Outcome Treatment
    1