BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL SOLUTIONS, DISTRIBUTOR, CONYERS, GEORGIA

    MDR report key: 1105925 · Received August 8, 2008

    Report

    Report Number
    MW5007950
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    June 2, 2008
    Report Date
    August 8, 2008
    Manufacturer
    SPINAL ELEMENTS
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A LUMBAR LAMINECTOMY, L4-5 WITH TRANSFORAMINAL INTERBODY FUSION. AFTER INSERTION OF THE CAGE, THE INSERTER WAS NOTED TO HAVE A 1/4 IN TINE BROKEN OFF REMAINING IN THE PATIENT. HOSPITAL STAFF ADVISED PHYSICIAN THAT THE BROKEN-OFF PRONG HAD TO BE REMOVED. PHYSICIAN DETERMINED THAT IT WAS TOO DARK IN THE DISC SPACE TO SEE THE PIECE OF METAL. THE ONLY WAY TO REMOVE THE PRONG WOULD BE TO USE AN ANTERIOR SURGICAL APPROACH. PHYSICIAN DETERMINED PATIENT'S STATE OF HEALTH WOULD NOT TOLERATE THE SURGERY REQUIRED. GENERAL SURGEON/CHIEF OF STAFF EXAMINED PATIENT AND AGREED WITH PRIMARY SURGEON THAT IT WOULD BE MEDICALLY PRUDENT TO LEAVE THE PRONG IN PLACE - THE RISKS OF REMOVAL OUTWEIGHED THE RISKS OF POTENTIAL INJURY IF LEFT IN PLACE. WHEN THE INSERTER WAS REMOVED, ONE OF THE TINES WAS NOTED TO BE MISSING, APPROXIMATELY 8MM LONG AND 1.5MM IN WIDTH. THE DISC SPACE WAS EXTENSIVELY EXPLORED, REMOVING ALL BONE GRAFT, USING A CURET AND PITUITARY RONGEUR TO GRASP ANY POTENTIAL METALLIC OBJECT. SINCE IT IS NOT REFLECTIVE, IT WAS VERY DIFFICULT TO SEE. X-RAY SHOWED THE SMALL PIECE WAS WITHIN THE DISC SPACE, BUT EXTENSIVE EFFORTS TO IDENTIFY AND REMOVE IT WERE UNSUCCESSFUL. MEDICAL CONSULTATION WITH CHIEF OF STAFF. DETERMINATION MADE THAT TINE COULD ONLY BE REMOVED BY ANTERIOR APPROACH AND DISCECTOMY. LIKELIHOOD OF COMPLICATION OR MIGRATION OF TINE WAS THOUGHT TO BE EXTREMELY LOW AND DID NOT WARRANT ADDITIONAL SURGICAL EXPLORATION. DATES OF USE: 6-8 MONTHS ESTIMATED. DIAGNOSIS OR REASON FOR USE: GRADE 1 L4-5 DEGENERATIVE SPONDYLOLISTHESIS, L4-5 KYPHOSIS AND L3 TO 5 STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL SOLUTIONS, DISTRIBUTOR, CONYERS, GEORGIA T-LIFT CAGE INSERTER LXH SPINAL ELEMENTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other