BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHATEC SOLUS LUMBER SPACER 12MM LARGE, 12MM LORDOTIC (TI-6AL-4V ELI, PEEK, TI)

    MDR report key: 4016896 · Received August 18, 2014

    Report

    Report Number
    2027467-2014-00025
    Event Type
    Injury
    Date Received
    August 18, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    OVD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF OCCURRENCE UNKNOWN AND HAS NOT BEEN PROVIDED. THIS CONFIGURATION OF THE ALPHATEC SOLUS LUMBER SPACER (25600-312-SEU) IN NOT AVAILABLE FOR USE OR SALE IN THE USA. AN EVALUATION OF THE SUSPECT DEVICE REVEALED NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. THE IMPLANT WAS FOUND TO BE PROPERLY MANUFACTURED AND RELEASED ACCORDING TO DESIGN SPECIFICATIONS. A PREVIOUS INVESTIGATION FOUND THAT THIS TYPE OF OCCURRENCE IS THE RESULTS OF THE PATENTS BONE CONDITION. PATIENTS WITH ISTHMIC SPONDY AND HIGHLY SCLEROTIC ENDPLATES MAY HAVE ADVERSE AFFECTS ON THE ANCHORING BLADES ABILITY TO BE DEPLOYED. THE SUPPLIED INSTRUCTIONS FOR USE PROVIDES BOTH WARNINGS AND PRECAUTIONS FOR THIS TYPE OF EVENT. INSTRUCTIONS FOR USE (INS-040); WARNINGS: 7. DO NOT USE WITH EXCESSIVELY DENSE VERTEBRAE. IN PATIENTS WHERE ONLY ONE OF THE TWO VERTEBRAE IS EXCESSIVELY DENSE THE SAFETY FEATURE BUILT INTO THE DEPLOYMENT WRENCH TIP WILL NOT BE EFFECTIVE PRECAUTIONS 7. BONE DENSITY, QUALITY, AND/OR STABILITY MAY HAVE ADVERSE AFFECTS ON THE ANCHORING BLADES ABILITY TO BE DEPLOYED OR MAINTAIN PURCHASE WITH THE BONE. THE ALPHATEC SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM IS A STAND ALONE ANTERIOR INTERBODY FUSION DEVICE THAT CAN ALSO BE USED WITH SUPPLEMENTAL FIXATION. IT 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 (PEEK OPTIMA LT1), TITANIUM (TI-6AL-4V ELI) ANCHORING BLADES AND TANTALUM RADIOGRAPHIC MARKERS. SYSTEM INSTRUMENTS ARE MANUFACTURED FROM STAINLESS STEEL.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER (BELGIUM) REPORTED THAT THE BLADES OF A 12MM SOLUS SPACER COULD NOT BE DEPLOYED TO PENETRATE THE PATIENT'S VERTEBRAL BODY. THE CASE WAS EXTENDED APPROXIMATELY 40 MINUTES IN ORDER TO REMOVE THE IMPLANT, RETRIAL THE PATIENT'S DISK SPACE AND REPLACE THE IMPLANT WITH A NEW SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494491 ALPHATEC SOLUS LUMBER SPACER 12MM LARGE, 12MM LORDOTIC (TI-6AL-4V ELI, PEEK, TI) ALPHATEC SOLUS ANTERIOR LUMBER INTERBODY FUSION OVD ALPHATEC SPINE INC 25600-312-SEU 653351

    Patients

    Seq Age Sex Outcome Treatment
    1 Other