BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEAL COLLAR 4.5X5.5, 3MM

    MDR report key: 8692302 · Received June 12, 2019

    Report

    Report Number
    0002023141-2019-00259
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    April 29, 2019
    Report Date
    September 26, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NHA
    PMA / PMN Number
    K111852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE HEAL COLLAR 4.5X5.5, 3MM (ITEM # HC453) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED PRODUCT DID NOT IDENTIFIED ANY MALFUNCTION. FUNCTIONAL TESTING WAS PERFORMED FOR THE RETURNED PRODUCT THE HEALING COLLARS DID NOT DISPLAY A MALFUNCTION AND THREADED EFFECTIVELY WHEN TESTED WITH AN IN-HOUSE COMPATIBLE IMPLANT. 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 REV1-01/15 INFORMATION IDENTIFIED: DESCRIPTION AND ADVERSE EFFECTS A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCES WERE NOTED. ALSO, A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS FOR THIS PRODUCT LOT. COMPLAINANT REPORTED TWO HEALING COLLARS (ADDITIONAL HEALING COLLAR WAS REPORTED ON (MFR - 0002023141 - 2019 - 00261- 1) WOULD NOT SCREW INTO THE IMPLANT. THE REPORTED EVENT COULD NOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. LOT NUMBER UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALING COLLAR (HC453) WOULD NOT SEAT INSIDE THE IMPLANT. ANOTHER HEALING COLLAR WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484436 HEAL COLLAR 4.5X5.5, 3MM HEALING COLLAR NHA ZIMMER DENTAL 2017091223

    Patients

    Seq Age Sex Outcome Treatment
    1