BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LLC - PEEK 5 DEGREES MEDIUM SPACER - 10MM X 25MM X 8MM

    MDR report key: 3941221 · Received July 17, 2014

    Report

    Report Number
    2027467-2014-00019
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    MQP
    PMA / PMN Number
    K050553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED BY THE SALES REP INDICATED TRIALS WERE NOT USED, THE DISK HEIGHT AND LENGTH WERE DETERMINED BY ROTARY SHAVERS. AN EVALUATION OF THE SUSPECT DEVICE REVEALED NO IRREGULARITIES. IT APPEARS INSTRUMENTATION MISUSE AS THE MOST LIKELY CAUSE OF THE FAILURE. THIS SURGICAL CASE WAS REPORTED TO HAVE PROCEEDED WITHOUT THE USE OF IMPLANT SIZE TRIALS TO DETERMINE THE CORRECT SIZE IMPLANT PRIOR TO PLACEMENT. MALLET IMPACTION WAS THEN UTILIZED TO MANEUVER THE IMPLANT INTO POSITION. AS A RESULT, LOADS EXCEEDING THE ULTIMATE STRENGTH OF THE IMPLANT WERE APPLIED CAUSING THE IMPLANT TO FAIL. SURGICAL TECHNIQUE (LIT-83193) INSTRUCTS THE USER TO INSERT A TRIAL UPON COMPLETION OF ENDPLATE PREPARATION TO CONFIRM THE CORRECT DISK HEIGHT. TRIALS ARE CLOSELY MATCHED TO THE HEIGHT, LORDOSIS AND FOOTPRINT OF THE IMPLANT. TRIALS SHOULD BE USED WHEN DECIDING THE APPROPRIATE IMPLANT TO USE DURING SURGERY. THESE TRIALS ARE DESIGNED TO MINIMIZE THE RISK OF DAMAGE TO THE IMPLANTS DURING A PROCEDURE WHILE ALSO HELPING THE SURGEON TO IDENTIFY THE BEST IMPLANT TO USE.

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO IMPLANT AN 8MM PEEK CAGE VIA IMPACTION, THE CAGE FRACTURED AND BROKE AT THE INSERTER INTERFACE RESULTING IN A DURA LEAK. THE FRACTURED SPACER SEPARATED INTO TWO PIECES. ONE OF THE SECTIONS REMAINED ATTACHED TO THE INSERTER AND WAS REMOVED WITHOUT ISSUE. THE SECOND SECTION WHICH CAUSED THE LEAK WAS REMOVED FROM THE DISK SPACE AND THE DURA TEAR SUTURED/REPAIRED WITHOUT FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419519 LLC - PEEK 5 DEGREES MEDIUM SPACER - 10MM X 25MM X 8MM MQP MQP ALPHATEC SPINE INC 64115-108 669306

    Patients

    Seq Age Sex Outcome Treatment
    1 Other