BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEEK PREVAIL CERVICAL INTERBODY DEVICE

    MDR report key: 3240773 · Received July 22, 2013

    Report

    Report Number
    1030489-2013-03073
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 20, 2013
    Report Date
    August 8, 2013
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    ODP
    PMA / PMN Number
    K094042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    CORRECTION/ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL REVIEW CONFIRMED THE IMPLANT IS BROKEN AT THE TOP OF ONE OF THE SCREW BOSSES. SYMMETRICAL NOTCHES CAN BE ATTRIBUTED TO EXCESSIVE FORCE OF THE IMPLANT HOLDER. FRACTURE SURFACE APPEARS FAIRLY BRITTLE, WITH RAYS EMANATING FROM THE ORIGIN OF CRACK PROPAGATION. THE SCREW BOSS DAMAGE IS CONSISTENT WITH OVERLOADING OF THE MATERIAL DURING IMPLANTATION. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH OVERLOAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SPINAL PROCEDURE. ¿IT WAS REPORTED THAT A PIECE OF THE SPACER BROKE OFF DURING INSERTION. THE BROKEN PIECE WAS RECOVERED AND SAFELY EXPLANTED, BUT WAS LOST WHEN THE DEVICE WAS WASHED AND AUTOCLAVED. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340793 PEEK PREVAIL CERVICAL INTERBODY DEVICE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP MSD DEGGENDORF MFG NA WC86

    Patients

    Seq Age Sex Outcome Treatment
    1