BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW FIXATION BONE

    MDR report key: 4476418 · Received February 2, 2015

    Report

    Report Number
    2520274-2015-10693
    Event Type
    Injury
    Date Received
    February 2, 2015
    Report Date
    January 22, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECONSTRUCTION OF ALVEOLAR DEFECTS USING TITANIUM-REINFORCED POROUS POLYETHYLENE AS A CONTAINMENT DEVICE FOR RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN 2 HART.K, BOWLES. D, AMERICAN ASSOCIATION OF ORAL AND MAXILLOFACIAL SURGEONS. J ORAL MAXILLOFAC SURG 70:811-820, 2012. THIS REPORT IS FOR AN UNKNOWN SCREW. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, A CASE REVIEW WAS PERFORMED OF 8 PATIENTS WHO HAD UNDERGONE RHBMP-2 BONE GRAFTING USING POROUS POLYETHYLENE AS THE CONTAINMENT DEVICE. EIGHT MAXILLARY AND TWO MANDIBULAR ALVEOLAR DEFECTS WERE GRAFTED USING RHBMP-2 AND TITANIUM-REINFORCED POROUS POLYETHYLENE AS A SOFT TISSUE BARRIER. ONE PATIENT RECEIVED AUTOLOGOUS RAMUS BONE IN ADDITION TO THE RHBMP-2. ALL PATIENTS WERE FOLLOWED UP BY CLINICAL EXAMINATION AND PERIODIC RADIOGRAPHIC STUDIES FOR 6 MONTHS TO 2 YEARS. IMPLANT-BORNE PROSTHESES WERE FABRICATED ON ALL SUCCESSFUL GRAFTS. A (B)(6) MAN THREE MONTHS POSTOPERATIVELY, A WOUND DEHISCENCE DEVELOPED, AND THE BARRIER WAS EXPOSED AT THE CREST OF THE RIDGE. AT 6 MONTHS POSTOPERATIVELY, THE MEMBRANE WAS REMOVED. THE GRAFTED REGION OF THE ALVEOLUS WAS FOUND TO HAVE SUCCESSFULLY GAINED WIDTH, BUT THE VERTICAL COMPONENT OF THE GRAFT WAS NOT SUCCESSFUL. OF THE 10 GRAFTED ALVEOLAR DEFECTS, 2 (20 PERCENT) RESULTED IN EARLY EXPOSURE OF THE CONTAINMENT DEVICES, WERE REMOVED, AND RESULTED IN NO BONE FORMATION. ONE OF THE 10 DEFECTS (10 PERCENT ) BECAME EXPOSED 3 MONTHS POSTOPERATIVELY AND RESULTED IN ONLY MODERATE BONE FORMATION. IN THE 7 NONEXPOSED CASES (70PERCENT), BONE FORMATION WAS EXCELLENT, AND IMPLANTS WERE SUCCESSFULLY PLACED. THIS IS 4 OR 4 REPORTS FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SCREW. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75278 SCREW FIXATION BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention