BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3738821 · Received April 10, 2014

    Report

    Report Number
    2027467-2014-00005
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 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

    THE RETURNED PEEK CAGE IS CURRENTLY BEING EVALUATED. A FOLLOW-UP REPORT WITH RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON COMPLETION. ADDITIONAL INFORMATION PROVIDED BY THE SALES REP REVEALED THAT TRIALS WERE NOT UTILIZED PRIOR TO THE FAILED ATTEMPT IN INSERTING THE 9MM PEEK CAGE. THE SURGEON ROUTINELY USES A PEDICLE SCREW DISTRACTION TO DISTRACT THE SPACE PRIOR TO IMPACTION. 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.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION INTO THE FRACTURED PEEK CAGE IDENTIFIED 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 REQUIRED IN AN ATTEMPT TO MANEUVER THE IMPLANT INTO THE CORRECT POSITION. AS A RESULT, LOADS EXCEEDING THE ULTIMATE STRENGTH OF THE IMPLANT WERE APPLIED CAUSING THE IMPLANT TO FAIL. ATTEMPTED PLACEMENT OF THE IMPLANT WITHOUT THE USE OF SIZE TRIALS IS IN DIRECT VIOLATION OF THE SURGICAL TECHNIQUE WHICH CLEARLY STATES THEIR USE IS NECESSARY TO AVOID APPLYING LOADS IN EXCESS OF THAT WHICH THE IMPLANT CAN WITHSTAND. IT IS STATED IN THE REPORT THAT THE SURGEON HAS USED THE SAME ABBREVIATED TECHNIQUE, NO USE OF TRIALS, FOR THE PAST FIVE YEARS. SINCE (B)(6) OF 2010, SEVEN OF THE 34 TOTAL COMPLAINTS FOR NOVEL SD CAGE FAILURES THAT ARE SIMILAR TO THIS REPORT ARE ATTRIBUTED TO THIS SURGEON. IT IS LIKELY THIS CAUSE WAS A CONTRIBUTING FACTOR IN THIS FAILURE.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT POSTERIOR LUMBER FUSION OF THE L1-L3 ON (B)(6) 2014. WHILE ATTEMPTING TO IMPLANT A 9MM PEEK CAGE VIA IMPACTION, IT FRACTURED AND BROKE AT THE INSERTER INTERFACE RESULTING IN A DURAL TEAR AT THE L1/2. THE DISK SPACE WAS PROPERLY CLEANED OUT AND FILLED WITH AUTOLOGOUS BONE GRAFT. THE SURGEON ELECTED NOT TO REPLACE THE FRACTURED 9MMPEEK CAGE WITH ALTERNATIVE SIZE. THE DURAL TEAR WAS REPAIRED WITHOUT FURTHER ISSUE VIA 4-0 NEUROLON SUTURE AND DURA SEAL. THERE DOES NOT SEEM TO BE ANY PATIENT COMPLICATIONS DUE TO THE TEAR/REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218488 SD PEEK MEDIUM SPACER - 9MM X 25MM X 9MM (PEEK) MQP MQP ALPHATEC SPINE INC 64815-009 658525

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other