BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEAL COLLAR 3.5X3.5, 5MM

    MDR report key: 6721991 · Received July 18, 2017

    Report

    Report Number
    0001038806-2017-00435
    Event Type
    Malfunction
    Date Received
    July 18, 2017
    Date of Event
    June 2, 2017
    Report Date
    October 10, 2017
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NHA
    PMA / PMN Number
    PK111852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE ZIMMER DENTAL HEAL COLLAR WAS RETURNED FOR INSPECTION. VISUAL INSPECTION REVEALED WEAR ABOUT THE COLLAR AND THE THREADS. THE HEX HEAD WAS ALSO SLIGHTLY WORN, BUT FUNCTIONAL. PRODUCT DIMENSIONS WERE FOUND TO CONFORM WITH PRINT SPECIFICATIONS WHERE MEASURED AGAINST DRAWING REF ECO# 112456 REV A. THE IMPLANT THAT ALLEGEDLY WOULD NOT MATE WAS NOT RETURNED FOR INSPECTION, THEREFORE THE REPORTED EVENT COULD NOT BE VERIFIED. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL COMPLAINTS GENERATED AGAINST THIS LOT NUMBER. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: INSTRUCTIONS FOR USE FOR HEALING COLLARS, HEALING SCREWS, SURGICAL COVER SCREWS AND TEMPORARY GINGIVAL CUFFS 9658 REV 1-01/15. HEALING COLLARS ¿ FOR USE WITH TAPERED SCREW-VENT®, SCREW-VENT® AND TRABECULAR METAL¿ IMPLANTS. SELECT THE APPROPRIATE SIZE HEALING COLLAR FOR THE PLATFORM OF THE IMPLANT AND WITH APPROPRIATE HEIGHT AND EMERGENCE PROFILE TO FIT THE EXISTING OR DESIRED TISSUE CONTOUR OF THE SITE. THE HEALING COLLARS ARE ANODIZED WITH COLOR-CODING ON THE LOWER PORTION TO INDICATE THE IMPLANT PLATFORM DIAMETER (FIGURE A). THE TOP SURFACE OF THE HEALING COLLAR IS ETCHED WITH THREE NUMBERS (FIGURE B) TO REFERENCE IMPLANT PLATFORM DIAMETER (LEFT), EMERGENCE PROFILE. DIAMETER (TOP RIGHT) AND CUFF HEIGHT (LOWER RIGHT). THE NUMBERS FOR IMPLANT PLATFORM AND EMERGENCE PROFILE SHOW ONLY THE INITIAL DIGIT OF THE RELATED MEASUREMENT. A SINGULAR CAUSE CANNOT BE DETERMINED. UDI NUMBER: (B)(4). THE DEVICE RETURN DATE IS (B)(6) 2017.

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT YET BEEN RETURNED TO MANUFACTURE. PRODUCT NO RETURNED TO MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HEALING COLLAR DOES NOT ASSEMBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502797 HEAL COLLAR 3.5X3.5, 5MM HEALING ABUTMENT NHA ZIMMER DENTAL 63571118

    Patients

    Seq Age Sex Outcome Treatment
    1