BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEEK PREVAIL CERVICAL INTERBODY DEVICE

    MDR report key: 2896620 · Received January 4, 2013

    Report

    Report Number
    1030489-2013-00015
    Event Type
    Injury
    Date Received
    January 4, 2013
    Report Date
    December 7, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    ODP
    PMA / PMN Number
    K073285
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT FUSE. THE PATIENT'S SYMPTOMS (NECK/RIGHT ARM PAIN) RETURNED THREE WEEKS FOLLOWING IMPLANTATION AT C4-5, AND THE IMPLANT WAS REMOVED 1 YEAR AFTER INITIAL ACDF. ANOTHER DEVICE WAS THEN IMPLANTED AT C4-5 WITH ANOTHER PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4124 PEEK PREVAIL CERVICAL INTERBODY DEVICE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention