BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWS

    MDR report key: 3813043 · Received May 15, 2014

    Report

    Report Number
    2520274-2014-11473
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 21, 2014
    Manufacturer
    DEPUY SYNTHES (USA)
    Product Code
    DZL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. BERKES, M. B., MD, LITTLE, M. T.M., MD, LAZARO, L. E. LAZARO, MD,, CYMERMAN, R. M. BA, HELFET D.L., MD, AND LORICH, D.G., MD. CATASTROPHIC FAILURE AFTER OPEN REDUCTION INTERNAL FIXATION OF FEMORAL NECK FRACTURES WITH A NOVEL LOCKING PLATE IMPLANT. ORTHOP TRAUMA, VOLUME 26, NUMBER 10, OCTOBER 2012. THIS REPORT IS FOR AN UNKNOWN SYNTHES SCREW. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED: NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. 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 THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: BERKES, M. B., MD, LITTLE, M. T.M., MD, LAZARO, L. E. LAZARO, MD,, CYMERMAN, R. M. BA, HELFET D.L., MD, AND LORICH, D.G., MD. CATASTROPHIC FAILURE AFTER OPEN REDUCTION INTERNAL FIXATION OF FEMORAL NECK FRACTURES WITH A NOVEL LOCKING PLATE IMPLANT. ORTHOP TRAUMA, VOLUME 26, NUMBER 10, OCTOBER 2012. THIS ARTICLE INVOLVES 21 FEMORAL NECK FRACTURES TREATED WITH THE POSTEROLATERAL FEMORAL LOCKING PLATE (SYNTHES, INC, PAOLI, PA) WERE ELIGIBLE FOR INCLUSION. EIGHTEEN MET INCLUSION/EXCLUSION CRITERIA WITH A MEAN FOLLOW-UP OF 16 MONTHS. SEVEN (36.8%) OF 18 CASES EXPERIENCED CATASTROPHIC FAILURE. MODES OF FAILURE INCLUDED BROKEN SCREWS WITH VARUS DISPLACEMENT IN 5 CASES INTRA-ARTICULAR PENETRATION OF THE FIXED-ANGLE SCREWS AFTER COLLAPSE OF THE HEAD FRAGMENT IN A SINGLE CASE AND DISSOCIATION OF THE DISTAL SCREW FROM THE SHAFT IN A SINGLE CASE. THERE WERE NO IDENTIFIABLE PATIENTS NOTED IN THIS ARTICLE. ALL EVENTS OCCURRED POSTOPERATIVELY. THE MEDWATCH WILL COVER SEVEN PATIENTS WITH BROKEN SCREWS WITH VARUS DISPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291199 SCREWS DZL DEPUY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention