BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    MDR report key: 11821861 · Received May 13, 2021

    Report

    Report Number
    0002023141-2021-01248
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    April 16, 2021
    Report Date
    September 2, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K111889
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED DATA AND ADDITIONAL INFORMATION. FOLLOWING REVIEW OF THE DHR, THE LOT NUMBER PROVIDED DID NOT MATCH THE ITEM/CATALOG NUMBER. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0002023141-2021-01247, 0002023141-2021-01247-1 AND 0002023141-2021-01247-2. THE PRODUCTS WERE RETURNED AND THE REPORTED EVENT WAS CONFIRMED FOLLOWING VISUAL EVALUATION. BASED ON THE EVALUATION, DEVICE MALFUNCTION HAS OCCURRED. HOWEVER, THERE IS NO EXISTING NONCONFORMANCE / CAPA / HHE/D / IE / PRODUCT HOLD AGAINST THE REPORTED DEVICES 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 DEVICES. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCTS WERE WITHIN SPECIFICATIONS AND CONFORMING WHEN THEY LEFT ZIMMER BIOMET. DHR REVIEW FOR THE LOTS (61700552 & 61688421) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBERS (61700552 & 61688421) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FRACTURE: IMPLANT) AND NO OTHER COMPLAINT WAS IDENTIFIED. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE PRODUCTS WERE FRACTURED. THEREFORE, THE REPORTED EVENT COULD NOT BE RECREATED. THE COMPLAINT IS RELATED TO THE FUNCTIONAL PERFORMANCE OF THE DEVICES. 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 PARAFUNCTIONAL HABITS OF THE PATIENT OVER THE IMPLANTATION PERIOD (SEVERE BRUXISM). NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE 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

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER ¿ K101880.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITE #30 & 31 WERE REMOVED DUE TO FRACTURE. LOOSENESS WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714529 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 61688421

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention