BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3770548 · Received April 24, 2014

    Report

    Report Number
    2027467-2014-00007
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 2, 2014
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    MQP
    PMA / PMN Number
    K050553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED BY THE SALES REP INDICATED THE DISK SPACE WAS PREPARED USING A 6MM AND 8MM SMOOTH DISTRACTOR PADDLES AND SUBSEQUENTLY SCRAPED WITH AN 8MM SHAVER. PEDICLE SCREW DISTRACTOR WAS USED TO DISTRACT THE SPACE PRIOR TO IMPACTING THE CAGE. THE SURGEON DOES NOT USE TRIALS AND ROUTINELY PREPARES THE SPACE IN THIS MANNER. SURGICAL TECHNIQUE (LIT-83194) INSTRUCTS THE USER TO INSERT A TRIAL UPON COMPLETION OF ENDPLATE PREPARATION. 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

    DURING AN L4-S1 POSTERIOR LUMBAR FUSION ON A (B)(6) FEMALE, A NOVEL SD PEEK CAGE FRACTURED UPON INSERTION AT THE INSERTER/CAGE INTERFACE. THE DETACHED FRAGMENTS WERE REMOVED FROM THE SURGICAL SITE WITHOUT ISSUE VIA PITUITARY FORCEPS. THE SURGEON WAS THEN ABLE TO PROPERLY POSITION THE REMAINDER OF THE CAGE IN THE PATIENTS L4-5 DISK SPACE. NO ADDITIONAL SURGERY WAS REQUIRED. NO PATIENT COMPLICATIONS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250155 SD PEEK MEDIUM SPACER - 9MM X 25MM X 9MM (PEEK) MQP MQP ALPHATEC SPINE INC 64815-009

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other