BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABUT GOLD FRICTION-FIT 3. 5MM IMP

    MDR report key: 12802557 · Received November 12, 2021

    Report

    Report Number
    0002023141-2021-03247
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Date of Event
    October 30, 2021
    Report Date
    April 27, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K011028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL PMA/510(K) NUMBER ¿ K013227/K953101. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT REMAINS IN USE; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. ONE (1) ABUT GOLD FRICTION-FIT 3. 5MM IMP (HLA3G) WAS NOT RETURNED FOR INVESTIGATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER ALONG WITH THE APPLICABLE INSTRUCTIONS FOR USE (IFU), AND RISK FILE. BASED ON THE EVALUATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED. ADDITIONAL, THERE IS NO EXISTING NONCONFORMANCE / CAPA / HHE/D / IE / PRODUCT HOLD AGAINST THE REPORTED DEVICE THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ADVERSE TRENDS OR ACTIONABLE TRENDS FOR THE REPORTED EVENT OR DEVICE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS WITHIN SPECIFICATIONS AND CONFORMING WHEN IT LEFT ZIMMER BIOMET. DHR REVIEW AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO PREVENT THE DISTRIBUTION OF NON-CONFORMING PRODUCT IS WITHIN SPECIFICATIONS. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE (HLA3G) DATING BACK TO 12 MONTHS PRIOR TO THE NOTIFICATION DATE. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED DEVICE RELATED TO THE REPORTED EVENT. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS NOT RETURNED. THEREFORE, THE REPORTED EVENT COULD NOT BE RECREATED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE MOST LIKELY CAUSES DETERMINED FROM THE INVESTIGATION ARE SCREW/PRODUCT NOT TORQUED TO SPECIFICATION, ABUTMENT CONE OVER-PREPPED; USER ERROR, INSUFFICIENT INSTRUCTIONS FOR USE, INSUFFICIENT TRAINING. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ABUTMENT SCREW WAS LOOSE. THE SCREW WAS TIGHTENED AND THE PATIENT WAS SENT HOME. NO INJURY TO PATIENT AND NO DAMAGE TO THE IMPLANT.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702698 ABUT GOLD FRICTION-FIT 3. 5MM IMP DENTAL SCREW DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown