BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE

    MDR report key: 13975323 · Received April 1, 2022

    Report

    Report Number
    0002023141-2022-00776
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    January 13, 2021
    Report Date
    July 26, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024015210
    PMA / PMN Number
    K011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER: K013227 AND K953101.

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. D9: DEVICE AVAILABLE FOR EVALUATION CHANGE ¿NO' TO 'YES'. G3: DATE RECEIVED BY THE MANUFACTURER. H1: TYPE OF REPORT, FOLLOW-UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES'. H6: EVALUATION CODES. H10: ADDITIONAL NARRATIVE. ONE ABUTMENT AND ASSOCIATED SCREW ATTACHED TO A CROWN WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED NO DAMAGE/MALFUNCTION. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICES AND EVENT. PRE-EXISTING CONDITION NOTED ON THE PER WAS ¿MODERATE BONE DENSITY ¿ TYPE II'. THE DEVICE WAS INTENDED FOR TOOTH #46 (FDI). X-RAY & PICTURE EVALUATION: X-RAY OR PICTURE IMAGE WAS NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE ¿ PROSTHETICS FOR ZIMMER DENTAL IMPLANT SYSTEMS ¿ IFU4894 REV 6 ¿ 08/19. INFORMATION IDENTIFIED: CONTRAINDICATIONS & PRECAUTIONS. PER THE APPLICABLE IFU, IT IS STATED THAT IMPROPER TECHNIQUES, SEVERE BRUXISM, CLENCHING, AND OVERLOADING, MAY CAUSE COMPONENT FRACTURE. DHR REVIEW: DHR REVIEW FOR THE LOT (2019061144) 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. LOTS WERE INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (2019061144) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FUNCTIONAL: LOOSENING) AND 1 OTHER COMPLAINT WAS IDENTIFIED UNDER (B)(4). POST MARKET TRENDING REVIEW: MAY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR. HOWEVER, THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT WERE UNVERIFIABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED LOOSENING SCREW , IT HAS BEEN REPLACED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900328 ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE DENTAL ABUTMENT DZE ZIMMER DENTAL HLA4/5 2019061144 00889024015210

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male