BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEAL COLLAR 3.5X4.5, 5MM

    MDR report key: 6791300 · Received August 14, 2017

    Report

    Report Number
    0001038806-2017-00492
    Event Type
    Injury
    Date Received
    August 14, 2017
    Date of Event
    May 17, 2017
    Report Date
    October 18, 2017
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NHA
    PMA / PMN Number
    PK111852
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LOT # WAS NOT PROVIDED/UNKNOWN.

    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. NO DEVICE LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD REVIEW AND A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. 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. PROBABLE CAUSES FOR THE COMPLAINT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED AS THE EVENT CANNOT BE RECREATED. COMPLAINT IS THEREFORE NON-VERIFIABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HEALING COLLAR DOES NOT ASSEMBLE IN TOOTH LOCATION#30. PATIENT HAS BEEN RESCHEDULED FOR NEW PROCEDURE FOR HEALING COLLAR PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572361 HEAL COLLAR 3.5X4.5, 5MM HEALING ABUTMENT NHA ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention