BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT GOLD FRICTION-FIT 3. 5MM IMP

    MDR report key: 15903204 · Received December 2, 2022

    Report

    Report Number
    0002023141-2022-02982
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    December 23, 2015
    Report Date
    April 11, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K011028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES.' H4: DEVICE MANUFACTURE DATE NOT AVAILABLE, LOT NUMBER UNKNOWN. PRODUCT EVALUATION: ONE HEALING ABUTMENT WAS RETURNED FOR INVESTIGATION, HOWEVER, THE SCREW WAS NOT RETURNED WITH THE ABUTMENT AND CROWN. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED SIGNS OF USE AND THE ABUTMENT WAS FRACTURED AT THE HEX. PLEASE SEE (B)(4) FOR DETAILS REGARDING THE FRACTURED ABUTMENT. THE INVESTIGATION FOR THIS COMPLAINT RECORD HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER ALONG WITH THE APPLICABLE INSTRUCTIONS FOR USE (IFU), AND RISK FILE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. A PRE-EXISTING CONDITION NOTED ON THE PER WAS BRUXISM. BONE DENSITY WAS UNKNOWN. THE REPORTED DEVICE WAS LOCATED ON TOOTH # 47 (FDI) AND WAS USED FOR APPROXIMATELY 6 YEARS. X-RAY & PICTURE EVALUATION: THE CUSTOMER DID NOT PROVIDE ANY IMAGES FOR THE REPORTED EVENT. 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 SEVERE BRUXISM, CLENCHING, AND OVERLOADING, MAY CAUSE BONE LOSS, SCREW LOOSENING, COMPONENT FRACTURE, AND/OR IMPLANT FAILURE. DHR REVIEW: DHR REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBERS ASSOCIATED TO THE ITEMS WERE NOT PROVIDED. HOWEVER, ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE HLA3G DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED PRODUCT FOR SIMILAR EVENT. REVIEW COMPLETED UTILIZING KEYWORDS: 'FUNCTIONAL : LOOSENING.' POST MARKET TRENDING REVIEW: JANUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION COULD NOT BE VERIFIED. WITHOUT RECEIPT OF ALL DEVICES, THE REPORTED EVENT IS NON-VERIFIABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SCREW LOOSENED. DISCOMFORT WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT PLACED ON (B)(6) 2014 AND CROWN PLACED ON (B)(6) 2015. PATIENT'S GOOD HEALTH CONDITION.

    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
    1796497 ABUT GOLD FRICTION-FIT 3. 5MM IMP DENTAL ABUTMENT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention