BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT GOLD FRICTION-FIT 3. 5MM IMP

    MDR report key: 12226548 · Received July 27, 2021

    Report

    Report Number
    0002023141-2021-01919
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    August 28, 2020
    Report Date
    December 30, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024015197
    PMA / PMN Number
    K011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE ABUT GOLD FRICTION-FIT 3. 5MM IMP (HLA3G) AND ONE COPING GOLD ENG 5.7 MM IM P (HLA5G) WERE REPORTED BUT NOT RETURNED FOR INVESTIGATION. THEREFORE, VISUAL EVALUATION COULD NOT BE PERFORMED. THE RETURNED MHLAS SCREW HAS BEEN MOVED TO ASSOCIATED ITEM AND PER CUSTOMER, THERE WERE NO ALLEGATIONS AGAINST IT. THE INVESTIGATION WAS PERFORMED USING APPLICABLE INSTRUCTIONS FOR USE (IFUS), RISK FILES AND OTHER AVAILABLE INFORMATION. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE PRODUCTS WERE NOT RETURNED. NO PRE-EXISTING CONDITIONS WERE NOTED. THE REPORTED DEVICES HAD BEEN PLACED ON TOOTH # 3 & 12 FOR APPROXIMATELY 2 YEARS. PICTURE OR X-RAY IMAGES WERE NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOTS (63838269 & 2018020402) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCE'S WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOTS WERE INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBERS (63838269 & 2018020402) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION AND THE REPORTED EVENT COULD NOT BE VERIFIED SINCE THE PRODUCTS WERE NOT RETURNED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER CMP-(B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED. DEVICE EXPIRATION DATE UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER: K013227, K953101.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT TOOTH LOCATION #12 - LOOSE ABUTMENT & SCREW TO REPLACE / CROWN AND IMPLANT BODY WERE FINE. PATIENT RETURNING FOR ADDITIONAL APPOINTMENT TO PLACE ENCODE & SCAN. AS A RESULT OF THIS EVENT, NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128124 ABUT GOLD FRICTION-FIT 3. 5MM IMP DENTAL ABUTMENT DZE ZIMMER DENTAL HLA3G 2018020402 00889024015197

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male