BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SD - PEEK MEDIUM SPACER SPACER - 9MM X 25MM X 10MM (PEEK)

    MDR report key: 3191259 · Received June 26, 2013

    Report

    Report Number
    2027467-2013-00017
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    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 REVEALED THE PATIENT UNDERWENT EXPLORATORY SURGERY WHICH CONFIRMED NO FRAGMENTS REMAINED IMPLANTED. THE REP ALSO STATED THAT TRIALS WERE NOT UTILIZED PRIOR TO THE FAILED ATTEMPT IN INSERTING THE 10MM PEEK CAGE. SURGICAL TECHNIQUE (LIT-83194) INSTRUCTS THE USER TO INSERT A TRIAL UPON COMPLETION OF ENDPLATE PREPARATION. TRAILS ARE CLOSELY MATCH TO THE HEIGHT, LORDOSIS AND FOOTPRINT OF THE IMPLANT. TRAILS 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. AN EVALUATION OF THE SUSPECT DEVICE REVEALED NO IRREGULARITIES. IT WAS DETERMINED THAT THERE WAS INADEQUATE DISK HEIGHT NECESSARY TO ALLOW INSERTION OF THE 10MM IMPLANT. A 9MM WAS ABLE TO BE INSERTED WITH THE AID OF PEDICLE SCREW DISTRACTION AND ADDITIONAL IMPACTION TO THE CAGE.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT UNDERWENT A LUMBAR FUSION ADDING L1 TO AN EXISTING L2-L5 FUSION. WHILE ATTEMPTING TO IMPLANT A 10MM PEEK CAGE, IT SHATTERED UPON IMPACTION LACERATING THE DURAL SACK AND THE L1 NERVE ROOT. THE BROKEN 10MM CAGE WAS REMOVED AND REPLACED WITH A 9MM USING PEDICLE SCREW DISTRACTION AND MINIMAL IMPACTION TO THE CAGE. ONCE THE CAGE WAS IN PLACE, THE SURGEON USED COMPRESSION ON THE PEDICLE SCREWS WHEN TIGHTENING THE CONSTRUCT. REPAIR OF THE DURAL SACK CAUSED OVER A 30 MINUTE DELAY IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290841 SD - PEEK MEDIUM SPACER SPACER - 9MM X 25MM X 10MM (PEEK) MQP MQP ALPHATEC SPINE INC 64815-010 638886

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other