BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEAL COLLAR 3.5X4.5, 3MM

    MDR report key: 6786319 · Received August 10, 2017

    Report

    Report Number
    0001038806-2017-00488
    Event Type
    Malfunction
    Date Received
    August 10, 2017
    Date of Event
    June 29, 2017
    Report Date
    October 18, 2017
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NHA
    PMA / PMN Number
    PK111852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN/NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    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 WITH TISSUE ATTACHMENT, BUT FUNCTIONAL. PRODUCT DIMENSIONS WERE FOUND TO CONFORM TO 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 A ROOT CAUSE FOR THE COMPLAINT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED AS THE EVENT CANNOT BE RECREATED. COMPLAINT IS THEREFORE NON-VERIFIABLE. UDI NUMBER: (B)(4).

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT DURING A PROCEDURE ON (B)(6) 2017, THE HEALING COLLAR (HC343) DID NOT SCREW INTO THE IMPLANT. DOCTOR TRIED TO SCREW THE HEALING COLLAR INTO SEVERAL ANALOGS BUT UNSUCCESSFULLY. DOCTOR COMPLETED THE PROCEDURE BY PLACING ANOTHER HEALING COLLAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564735 HEAL COLLAR 3.5X4.5, 3MM HEALING ABUTMENT NHA ZIMMER DENTAL 63346429

    Patients

    Seq Age Sex Outcome Treatment
    1