BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® STRAIGHT HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H)

    MDR report key: 9647897 · Received January 30, 2020

    Report

    Report Number
    0001038806-2020-00215
    Event Type
    Malfunction
    Date Received
    January 30, 2020
    Date of Event
    January 7, 2020
    Report Date
    April 16, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    NHA
    PMA / PMN Number
    K072642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CERTAIN® STRAIGHT HEALING ABUTMENT (ISHA43) WAS REPORTED BUT NOT RETURNED FOR INVESTIGATION. HOWEVER, THE T3 NON-PLATFORM SWITCHED IMPLANT (BOST485) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED IMPLANT IDENTIFIED THAT THE DEVICE WAS IN GOOD CONDITION. FUNCTIONAL TESTING WAS PERFORMED USING AN IN-HOUSE DRIVER. THE DRIVER WAS ABLE TO ENGAGE AND DISENGAGE WITH THE IMPLANT SUCCESSFULLY. PRE-EXISTING CONDITIONS, X-RAY IMAGE AND IMPLANTATION PERIOD ARE IRRELEVANT TO THIS INVESTIGATION. DOCTOR WAS ATTEMPTING TO PLACE DEVICES ON TOOTH #14 (UNIVERSAL) WHEN THE INCIDENT OCCURRED. PICTURES WERE NOT PROVIDED. DHR REVIEW FOR THE LOT (1231367) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE LOT (1231367) FOR SIMILAR EVENT AND NO OTHER COMPLAINT ABOUT NONCONFORMING PRODUCTS WAS IDENTIFIED. FEBRUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICES. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND FUNCTIONAL TESTING, IMPLANT-RELATED MALFUNCTION DID NOT OCCUR AND ABUTMENT-RELATED MALFUNCTION COULD NOT BE VERIFIED AS IT WAS NOT RETURNED. A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED. HOWEVER, THE PROBABLE CAUSES MAY BE RELATED TO A CLINICIAN CROSS-THREADS HEALING ABUTMENT OR CLINICIAN OVER-TORQUES HEALING ABUTMENT DURING PLACEMENT OF THE DEVICE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D4: UNIQUE IDENTIFIER (UDI) NUMBER. D4: EXPIRATION DATE. G4: DATE RECEIVED BY MANUFACTURER. G7: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). AGE: NOT PROVIDED. PATIENT WEIGHT: NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANT PLACEMENT, DOCTOR WAS UNABLE TO SEAT THE HEALING ABUTMENT (ISHA43) AND THEREFORE, HE REMOVED BOTH THE IMPLANT AND THE HEALING ABUTMENT. DOCTOR PLACED A NEW IMPLANT WITH A COVER SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111685 CERTAIN® STRAIGHT HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) DENTAL HEALING ABUTMENT NHA BIOMET 3I 1231367

    Patients

    Seq Age Sex Outcome Treatment
    1