BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEEK PREVAIL CERVICAL INTERBODY DEVICE

    MDR report key: 2080347 · Received May 6, 2011

    Report

    Report Number
    1030489-2011-00517
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 8, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    OVE
    PMA / PMN Number
    K073285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLATE: IMPLANT: 2006; EXPLANT: 2011-04-06. SCREWS: IMPLANT: 2011-04-06; EXPLANT: 2011-04-06. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A ONE LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) REVISION FOLLOWING A MOTOR VEHICLE ACCIDENT. THE SURGEON ATTEMPTED TO REPLACE A SIZE 5 INTERBODY DEVICE WITH A SIZE 6 INTERBODY DEVICE AT C3/4. THERE WAS NO ISSUE IMPLANTING THE TOP SCREW, HOWEVER, WHILE PLACING THE BOTTOM SCREW THE INTERBODY DEVICE BROKE. THE BOTTOM SCREW WENT THROUGH THE INTERBODY CAUSING IT TO BREAK THROUGH THE INTERBODY SCREW HOLE SINKING WAY BELOW THE LOCKING RING. THE PHYSICIAN REMOVED THE SIZE 6 INTERBODY DEVICE AND THE PREVIOUS PLATE. THE PHYSICIAN REPLACED THE DEVICES WITH A ONE LEVEL PLATE AND AN NEW INTERBODY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEEK PREVAIL CERVICAL INTERBODY DEVICE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL OVE MEDTRONIC SOFAMOR DANEK NA RG40

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR