BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHATEC SOLUS LUMBER SPACER, 12MM, MEDIUM, 12° LORDODIC

    MDR report key: 3894200 · Received June 25, 2014

    Report

    Report Number
    2027467-2014-00013
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    OVD
    PMA / PMN Number
    K123993
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE SUSPECT DEVICE CANNOT BE PERFORMED. THE IMPLANT REMAINS SECURELY ANCHORED WITHIN THE PATIENTS L5/S1 VERTEBRAL BODY. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES. LOT 658998 WAS PROPERLY MANUFACTURED AND RELEASED ACCORDING TO DESIGN SPECIFICATIONS. INSTRUCTIONS FOR USE ((B)(4)); THE ALPHATEC SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM IS AN INTERVERTEBRAL BODY FIXATION SYSTEM CONSISTING OF IMPLANTS WITH VARIOUS HEIGHTS AND LORDOSIS TO ACCOMMODATE INDIVIDUAL PATIENT PATHOLOGY. SYSTEM IMPLANTS ARE MANUFACTURED FROM IMPLANT GRADE POLYETHERETHERKETONE ((B)(4)), TITANIUM ((B)(4)) ANCHORING BLADES AND TANTALUM RADIOGRAPHIC MARKERS. THE ALPHATEC SOLUS IMPLANT IS INTENDED FOR USE WITH SUPPLEMENTAL SPINAL FIXATION. SPECIFICALLY, THE ALPHATEC SOLUS IMPLANT IS TO BE USED WITH THE ALPHATEC'S ZODIAC® SPINAL FIXATION SYSTEM, ASPIDA[?] ANTERIOR LUMBAR PLATING SYSTEM, ILLICO® MIS POSTERIOR FIXATION SYSTEM, ILLICO® FS FACET FIXATION SYSTEM, OR THE BRIDGEPOINT[?] SPINOUS PROCESS FIXATION SYSTEM. WARNINGS: IMPLANT BLADES MUST BE FULLY DEPLOYED INTO BOTH VERTEBRAE WHEN IMPLANTED. PRECAUTIONS: BONE DENSITY, QUALITY, AND/OR STABILITY MAY HAVE ADVERSE AFFECTS ON THE ANCHORING BLADES ABILITY TO BE DEPLOYED OR MAINTAIN PURCHASE WITH THE BONE.

    Description of Event or Problem · 1

    DURING A ONE LEVEL ALIF (ANTERIOR LUMBER INTERBODY FUSION) PROCEDURE PERFORMED ON (B)(6) 2014, THE DISTAL BLADE OF A 12MM SOLUS SPACER COULD NOT BE DEPLOYED WITHIN THE PATIENT'S L5/S1 ENDPLATES. THE SPACER REMAINS CONFINED WITHIN THE DISK SPACE VIA SUPPLEMENTAL FIXATION AND ONE DEPLOYED BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370275 ALPHATEC SOLUS LUMBER SPACER, 12MM, MEDIUM, 12° LORDODIC OVD OVD ALPHATEC SPINE INC 25200-312-S 658998

    Patients

    Seq Age Sex Outcome Treatment
    1 Other