BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVERLOC VOLAR PLATE SHEATH, RADIAL, RIGHT

    MDR report key: 1077281 · Received July 15, 2008

    Report

    Report Number
    1226487-2008-00002
    Event Type
    Malfunction
    Date Received
    July 15, 2008
    Date of Event
    June 6, 2008
    Report Date
    July 8, 2008
    Manufacturer
    DVO
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE FAILURE OBSERVED IS BELIEVED TO BE THE RESULT OF A CONDITION THE PLATE WAS NOT DESIGNED TO WITHSTAND - A PROLONGED NONUNION CAUSED BY AN ONSITE INFECTION. INFORMATION FROM THE SURGEON INDICATES THE INITIAL FRACTURE WAS HIGHLY COMMINUTED. THE HIGHER THE COMMINUTION, THE HIGHER THE RISK FOR NONUNION. THE PLATE IS DESIGNED FOR INITIAL FIXATION AND STABILIZATION OF A FRACTURE DURING THE HEALING PROCESS - IT IS NOT DESIGNED TO WITHSTAND THE FORCES GENERATED IN A NONUNION. IT IS ALSO NOT DESIGNED TO BE USED IN THE PRESENCE OF AN INFECTION, AS IS STATED IN THE IFU (INSTRUCTIONS FOR USE). THE SURGEON STATED IN AN EMAIL THAT IT IS HIS BELIEF THAT THE DEVICE DID NOT CAUSE THE INFECTION; IT IS STANDARD PROCEDURE TO REMOVE THE IMPLANT AND DEBRIDE THE WOUND IF AN INFECTION PERSISTS. THIS PRODUCT HAS BEEN ON THE MARKET SINCE FEBRUARY OF 2006. OVER 2000 SURGERIES HAVE BEEN DONE SINCE THEN USING THIS PRODUCT AND VARIOUS OTHER SIZES: NO ADVERSE EVENTS HAVE BEEN RECORDED. A VISUAL INSPECTION WAS DONE ON THE RETURNED PLATE, AND NO DEFECTS WERE SEEN. ALL EFFECTED PRODUCTS WERE ALL REASSEMBLED IN THE OFFICE AND NO DEFECTS WERE SEEN. INSPECTION CRITERIA AND MATERIAL SPECS HAVE BEEN REVIEWED, AND ALL EFFECTED PRODUCT MEETS THE REQUIREMENTS. THE RETURNED PLATE WAS ALSO EVALUATED WITH THE SCREW GAUGE, AND THE PRODUCT WAS WITHIN TOLERANCE, EVEN AFTER USAGE.

    Description of Event or Problem · 1

    AT THE THIRD FOLLOW-UP VISIT, THE PATIENT WAS EXAMINED AND FOUND TO HAVE AN INFECTION AND NON-UNION AT THE FRACTURE SITE. STANDARD TREATMENT FOR THIS EVENT REQUIRES THAT ALL INTERNAL FIXATION DEVICES BE REMOVED TO FACILITATE HEALING. AT THAT TIME, THE PHYSICIAN FOUND THAT TWO OF THE BONE SCREWS USED IN THE PREVIOUS SURGERY HAD BACKED OUT AND CAUSED THE BONE PLATE TO LOOSEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVERLOC VOLAR PLATE SHEATH, RADIAL, RIGHT BONE FIXATION ACCESSORY HRS DVO 0011219 AA0228

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other