BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHATEC SOLUS LUMBER SPACER, STERILE (TI-6AL

    MDR report key: 4421593 · Received January 15, 2015

    Report

    Report Number
    2027467-2014-00048
    Event Type
    Malfunction
    Date Received
    January 15, 2015
    Date of Event
    December 15, 2014
    Report Date
    December 18, 2014
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    OVD
    PMA / PMN Number
    K123993
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE SUSPECT DEVICE CANNOT BE PERFORMED. THE SOLUS SPACER REMAINS SECURELY ANCHORED WITHIN THE PATIENTS L5/S1 VIA SUPPLEMENTAL FIXATION. REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE IMPLANTS WERE PROPERLY MANUFACTURED AND RELEASED ACCORDING TO DESIGN SPECIFICATIONS. TWO SEPARATE SOLUS IMPLANT PART NUMBERS WERE UTILIZED DURING THE CASE. IT IS UNKNOWN WHICH FRACTURED. · 25200-114-SEU; LOT 652399 - ALPHATEC SOLUS LUMBER SPACER 14MM MEDIUM, 7° LORDOTIC, MANUFACTURED DATE: 12/29/2012, EXPIRATION DATE: 2/28/2015. · 25200-312-SEU; LOT 666238 - ALPHATEC SOLUS LUMBER SPACER 12MM MEDIUM, 12° LORDOTIC, MANUFACTURED DATE: 11/27/2013, EXPIRATION DATE: 2/28/2015. THESE CONFIGURATIONS OF THE ALPHATEC SOLUS LUMBER SPACER (25200-114-SEU & 252-312-SEU) ARE NOT AVAILABLE FOR USE OR SALE IN THE USA. EXAMINATION OF THE SUPPLIED IMAGES INDICATES THE BLADE OF THE SOLUS SPACER MAY HAVE CONTACTED THE FRACTURED SCREW (PREVIOUSLY LEFT IN THE PATIENT) WHILE DEPLOYING THE BLADES TO PENETRATE/ANCHOR WITHIN THE VERTEBRAL BODY.

    Description of Event or Problem · 1

    DURING DEPLOYMENT OF ONE OF THE SOLUS LUMBER SPACERS UTILIZED IN THE TWO-LEVEL 360 PROCEDURE, THE SURGEON HEARD A CRACKING NOISE. HE INITIALLY THOUGHT IT WAS SOMETHING TO DO WITH THE EXISTING BROKEN SCREW PREVIOUSLY LEFT IN THE PATIENT. UPON LOOKING AT A FULL A-P IMAGE IT WAS NOTED THAT ONE OF THE SOLUS BLADES HAD FRACTURED AND BROKE. THE SURGEON IS CONFIDENT THAT NO CONTINGENCIES FOR REVISION ARE REQUIRED AS ONE BLADE IS FULLY ENGAGED WITHIN THE FEMALE PATIENT'S VERTEBRAL BODY. ADDITIONAL POSTERIOR FIXATION SECURES THE IMPLANT WITHIN THE L5/S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36247 ALPHATEC SOLUS LUMBER SPACER, STERILE (TI-6AL OVD OVD ALPHATEC SPINE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other