BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MMSI SINGLE INNER SETSCREW

    MDR report key: 3285044 · Received August 14, 2013

    Report

    Report Number
    1526439-2013-23729
    Event Type
    Injury
    Date Received
    August 14, 2013
    Date of Event
    July 24, 2013
    Report Date
    July 24, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MNH
    PMA / PMN Number
    PK030383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. DEVICE REMAINS IN PATIENT.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION AND FUNCTIONAL EVALUATION OF THE INSTRUMENTS REPORTED AS DAMAGED IN THE CASE WAS CONDUCTED. ALL INSTRUMENTS PERFORMED AS INTENDED WITH NO VISUAL ANOMALIES NOTED. THE MMSI SINGLE INNER SETSCREW (PRODUCT CODE: 179712000, LOT NO: UNKNOWN) WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. AS NO LOT NUMBER IS AVAILABLE A DHR REVIEW COULD NOT BE CONDUCTED. A 12 MONTH COMPLAINT REVIEW OF THE MIS INNER SET SCREW IDENTIFIED NO SYSTEMIC TRENDS. AS NO COMPLAINT TREND HAS BEEN IDENTIFIED AND A DHR SEARCH COULD NOT BE CONDUCTED THE FILE WILL BE CLOSED. IF THE PATIENT IS REVISED AND THE INNER SETSCREW RETURNED FOR EVALUATION THE COMPLAINT FILE WILL BE RE-OPENED AND INVESTIGATED AT THAT TIME.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT MINIMALLY INVASIVE SURGERY (MIS) WAS PERFORMED ON (B)(6) 2013 USING VIPER SYSTEM POLYAXIAL SCREWS. SURGICAL INSTRUMENTS WERE DAMAGED DURING THE PROCEDURE BUT THE POST OPERATIVE X-RAYS WERE FINE. X-RAYS TAKEN ONE MONTH POST OP REVEALED ONE SET SCREW HAD LOOSENED. IT IS REPORTED THAT REVISION SURGERY IS NOT PLANNED AT THIS TIME AS THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE AFFECTS. CONCOMITANT DEVICES: EXPEDIUM DEROTATION STANDARD REDUCTION HANDLE, 286735735; EXPEDIUM DEROTATION REDUCTION SHAFT, 286735725; EXPEDIUM DEROTATION REDUCTION CAP 286735750; EXPEDIUM DEROTATION REDUCTION THREADED POST, 286735730; VIPER POLYAXIAL SCREW, CATALOG# UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389954 MMSI SINGLE INNER SETSCREW ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION MNH DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention