BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-LIF INTERVERTEBRAL BODY FUSION DEVICE

    MDR report key: 2139292 · Received June 17, 2011

    Report

    Report Number
    3005977257-2011-00003
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 17, 2011
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    MAX
    PMA / PMN Number
    K092815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND WAS FOUND TO MEET QUALITY REQUIREMENTS. IT WAS REPORTED AND THE FILMS OF THE APPLICABLE IMAGING STUDIES CONFIRMED THAT THE SURGEON DID NOT USE ANY TYPE OF SUPPLEMENTAL SPINAL FIXATION AFTER IMPLANTING THE S-LIF IBF DEVICES. IT IS LIKELY THAT THE S-LIF IBF DEVICES BACKED OUT OF THE PATIENT'S DISC SPACE BECAUSE SUPPLEMENTAL SPINAL FIXATION WAS NOT USED TO HELP STABILIZE THE SPINE FOR PROPER FUSION. DEVICE LABELING WAS REVIEWED AND IT IS NOTED IN THE INDICATIONS FOR USE STATEMENT THAT "THE SPINEFRONTIER S-LIF INTERVERTEBRAL BODY FUSION DEVICE IS INTENDED TO BE USED WITH SUPPLEMENTAL SPINAL FIXATION SYSTEM(S) CLEARED FOR USE IN THE LUMBAR SPINE." THE S-LIF IBF DEVICE IS NOT INTENDED TO BE USED AS A STANDALONE DEVICE. THIS IS CLEARLY STATED IN ALL LABELING FOR THE S-LIF IBF DEVICE SYSTEM. IT HAS BEEN CONCLUDED THAT THE DEVICE WAS NOT USED ACCORDING TO LABELED INDICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD RECEIVED A TWO LEVEL LUMBAR INTERVERTEBRAL BODY FUSION ON (B)(6) 2011. DURING THE FINAL POST-OP FOLLOW-UP WITH THE PATIENT, IT WAS OBSERVED ON X-RAY THAT BOTH S-LIF IBF DEVICES WERE BACKING OUT OF THE PATIENT'S DISC SPACE. PATIENT WAS REVISED ON (B)(6) 2011. THE DEVICES WERE REMOVED AND REPLACED WITH AN ALTERNATE INTERVERTEBRAL BODY FUSION DEVICES. THERE WAS NO PERMANENT IMPAIRMENT/DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-LIF INTERVERTEBRAL BODY FUSION DEVICE MAX SPINEFRONTIER, INC. IM50052-13 676103

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention