BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIMEND ADV 30 X 40

    MDR report key: 2479451 · Received February 23, 2012

    Report

    Report Number
    2523190-2012-00020
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Report Date
    February 23, 2012
    Manufacturer
    INTEGRA YORK, PA INC
    Product Code
    LYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL, AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    "THE DOCTOR TRIED THE HELI-MEND ADVANCED WITH A SCREW AND SAID IT JUST DID NOT HAVE THE STRENGTH YOU WOULD EXPECT A COLLAGEN MEMBRANE TO HAVE, AS A RESULT THE SCREW POPPED LOOSE AND THE MEMBRANE FELL OUT." ON (B)(6) 2012, THE ORAL SURGEON SAID HE PERFORMED A BONE GRAFT USING FREEZE DRIED BONE. HE PLACED A SMALL SCREW TO STABILIZE THE GRAFT WITH THE HEAD OF THE SCREW (WHICH WAS RAISED 4 MILLIMETERS ABOVE THE BONE SURFACE). HE PACKED FREEZE DRIED BONE AROUND THE SCREW AND COVERED THE GRAFT, FREEZE DRIED BONE AND THE SCREW WITH THE HELIMEND COLLAGEN DRESSING. HE SAW THE PT ONE WEEK LATER AND THE FLAP WAS CLOSED BUT THE HEAD OF THE SCREW PERFORMED THROUGH THE MEMBRANE. THE ORAL SURGEON HAD TO REMOVE THE SCREW FROM THE BONE GRAFT SITE. AT THE TIME OF THE REPORT, THE ORAL SURGEON REPORTED THE BONE GRAFT LOOKED OK AND WAS HEALING; BUT IT MAY NEED TO BE REDONE IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELIMEND ADV 30 X 40 M54 - ORAL SURGERY LYC INTEGRA YORK, PA INC

    Patients

    Seq Age Sex Outcome Treatment
    1