BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEEK PREVAIL CERVICAL INTERBODY DEVICE

    MDR report key: 2080340 · Received May 6, 2011

    Report

    Report Number
    1030489-2011-00516
    Event Type
    Injury
    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
    Adverse Event
    Yes
    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: 03/2011; EXPLANT: 2011-04-06. (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) FROM C4 TO C7 FIVE YEARS AGO WITH A COMPETITOR PLATE. IN THE BEGINNING OF (B)(6) 2011 THE PATIENT FELL AND HAD A SIZE 5 INTERBODY DEVICE IMPLANTED AT C3-4. THE END OF (B)(6) THE PATIENT WAS IN A MOTOR VEHICLE ACCIDENT. X-RAY AND MRI SHOWED THAT THE BOTTOM SCREW OF THE INTERBODY DEVICE BACKED OUT. THE PATIENT UNDERWENT REVISION SURGERY. IT WAS NOTED DURING REVISION SURGERY THAT THE LOCKING RING ON THE TOP SCREW HAD BROKEN AND THE BOTTOM LOCKING RING HAD BENT CAUSING THE BOTTOM SCREW TO BACK OUT. THE PHYSICIAN REMOVED THE SIZE 5 INTERBODY DEVICE AND TWO SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEEK PREVAIL CERVICAL INTERBODY DEVICE OVE MEDTRONIC SOFAMOR DANEK, NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention