BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHATEC SOLUS LUMBER SPACER, 12MM MEDIUM, 12° LORDOTIC, STERILE

    MDR report key: 4149798 · Received October 7, 2014

    Report

    Report Number
    2027467-2014-00031
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    OVD
    PMA / PMN Number
    K123993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE RETURNED SOLUS SPACER REVEALED NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. THE IMPLANT WAS FOUND TO BE PROPERLY MANUFACTURED AND RELEASED ACCORDING TO DESIGN SPECIFICATIONS. THE SALES REP STATED "THE BLADES FAILED TO DEPLOY DUE TO BOTH THE SURGEON AND REP'S LACK OF EXPERIENCE". VISUAL INSPECTION FOUND THE PROXIMAL BLADE APPEARS TO HAVE BEEN ROTATED THE INCORRECT DIRECTION. THE DULL NON-ANCHORING SIDES OF THE PROXIMAL BLADES ARE PROTRUDING FROM THE PEEK SPACER INDICATING THE HANDLES WERE NOT PULLED TOWARDS EACH OTHER SIMULTANEOUSLY AS INSTRUCTED IN THE SURGICAL TECHNIQUE (LIT-84335). THE PROVIDED INSTRUCTION FOR USE (INS-060) PROVIDES WARNING FOR THIS TYPE OF OCCURRENCE. PRECAUTIONS THE IMPLANTATION OF THE INTERVERTEBRAL BODY FUSION DEVICE SHOULD BE PERFORMED ONLY BY EXPERIENCED SPINAL SURGEONS WITH SPECIFIC TRAINING IN THE USE OF THIS DEVICE BECAUSE THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT. PREOPERATIVE MANAGEMENT THE SURGEON SHOULD HAVE A COMPLETE UNDERSTANDING OF THE SURGICAL TECHNIQUE AND OF THE DEVICE, INDICATIONS, CONTRAINDICATIONS AND APPLICATIONS. INTRAOPERATIVE MANAGEMENT: THE SURGICAL TECHNIQUE MANUAL SHOULD BE FOLLOWED CAREFULLY.

    Description of Event or Problem · 1

    THE BLADES OF A 12MM SOLUS SPACER FAILED TO DEPLOY DUE TO BOTH THE SURGEON AND SALES REP'S LACK OF EXPERIENCE IN THE USE OF THE SYSTEM. THE SOLUS SPACER WAS REMOVED & REPLACED CAUSING APPROXIMATELY 30 TO 45 MINUTE DELAY IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629327 ALPHATEC SOLUS LUMBER SPACER, 12MM MEDIUM, 12° LORDOTIC, STERILE OVD OVD ALPHATEC SPINE INC 25200-312-S 644757-G01

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other