BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM

    MDR report key: 2490015 · Received March 13, 2012

    Report

    Report Number
    2027467-2012-00007
    Event Type
    Injury
    Date Received
    March 13, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 14, 2012
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWQ
    PMA / PMN Number
    K101255
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE ASPIDA PLATING CONSTRUCT IS CURRENTLY BEING CONDUCTED. UPON COMPLETION, A FOLLOW-UP REPORT WITH RESULTS OF THE INVESTIGATION WILL BE SUBMITTED. THE CONSTRUCT CONSISTS OF: 18MM SACRAL PLATE, P/N: 51002-18, LOT: 6067534, QTY: 1, MFG DATE: 11/08/2010; ALIF SCREW 7.0MM X 30MM, P/N: 51070-30, LOT: 640944, QTY: 2, MFG DATE: 8/16/2011; ALIF SCREW 6.0MM X 30MM, P/N: 51060-30, LOT: 635874, QTY: 2, MFG DATE: 10/21/2010. THE ASPIDA ANTERIOR LUMBAR PLATING SYSTEM IS A TEMPORARY DEVICE USED TO STABILIZE THE LUMBAR SPINE DURING BONE FUSION DEVELOPMENT. DEVICE IMPLANTS INCLUDE TWO STYLES OF PLATE IN A RANGE OF SIZES AND BONE SCREWS TO PROVIDE THE VERSATILITY REQUIRED FOR THE SPECIFIC INDICATIONS NOTED. FIXATION IS ACHIEVED BY MEANS OF A RIGID PLATE THAT IS SURGICALLY ATTACHED TO THE SPINE WITH BONE SCREWS. IMPLANT PLATES AND BONE SCREWS ARE MANUFACTURED FROM (B)(4). ALL DEVICE COMPONENTS ARE INTENDED FOR FIXATION/ATTACHMENT TO THE ANTERIOR LUMBAR SPINE ONLY. IT IS INTENDED THAT THE IMPLANTS BE REMOVED AFTER SUCCESSFUL FUSION.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE ASPIDA PLATING CONSTRUCT FOUND NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. THE SUPPLIED X-RAY SHOWS THE ASPIDA PLATING CONSTRUCT CONSISTING OF ONE PLATE AND FOUR SCREWS MIGRATED AS A COMPLETE ASSEMBLY AWAY FROM THE ANTERIOR SURFACE OF THE PATIENT'S SPINE. THERE IS NO EVIDENCE THAT THE PLATE/SCREW INTERFACE OR LOCKING TAB FAILED TO FUNCTION AS INTENDED. AS A RESULT, THE BONE THREAD SECTIONS OF THE ANCHORING SCREWS WERE INSPECTED IN WHICH NO ANOMALIES WERE DETECTED. THE INVESTIGATION CONCLUDED ALL THE COMPONENTS WHICH MAKE UP THE ASPIDA PLATING CONSTRUCT WERE PROPERLY MANUFACTURED AND RELEASED TO DESIGN SPECIFICATIONS. IT APPEARS THE PATIENT'S COMPROMISED BONE QUALITY DID NOT ALLOW FOR SECURE ANCHORING OF THE FOUR BONE SCREWS.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012 TO REMOVE AN ASPIDA PLATING SYSTEM WHICH HAD MIGRATED FROM THE ANTERIOR SURFACE OF THE LUMBAR SPINE. POST-OP X-RAYS REVEALED THAT ALTHOUGH ALL FOUR SCREWS REMAINED CONFINED BY THE PLATES LOCKING MECHANISM, ONE SCREW HAD BEGAN TO LIFT OUT OF THE L5 VERTEBRAL BODY AND ONE FROM THE S1 SACRUM. THE ASPIDA ANTERIOR LUMBAR PLATING SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2012. NO IRREGULARITIES WERE REPORTED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM KWQ KWQ ALPHATEC SPINE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention