BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP TM 6.0MM MTX FULL, 10

    MDR report key: 11100239 · Received December 31, 2020

    Report

    Report Number
    0002023141-2020-02439
    Event Type
    Malfunction
    Date Received
    December 31, 2020
    Report Date
    February 25, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018969
    PMA / PMN Number
    K132258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: H6: COMPONENT CODE WAS ADDED: 4755. H6: TYOE OF INVESTIGATION CODES WERE ADDED: 4109, 4114 AND 3331. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 3221. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 4310. THE PRODUCT WAS NOT RETURNED. THEREFORE, THE REPORTED EVENT COULD NOT BE VERIFIED. BASED ON THE EVALUATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED. ADDITIONALLY, 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 EVENTS. 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 PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS WITHIN SPECIFICATIONS AND CONFORMING WHEN IT LEFT ZIMMER BIOMET. DHR REVIEW FOR THE LOT (1221504) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT (1221504) AND NO SIMILAR EVENT OR COMPLAINT WAS FOUND. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS NOT RETURNED. THEREFORE, THE REPORTED EVENT COULD NOT BE RECREATED. BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE MOST LIKELY CAUSE DETERMINED FROM THE INVESTIGATION IS EXCESSIVE LOADING ON ABUTMENT AND IMPLANT ASSEMBLY. NO FURTHER INVESTIGATION OR IMMEDIATE 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.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED. FAX NUMBER UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER ¿ K113753/K112160. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME OF THE THREADS ARE STRIPPED ON THE INSIDE OF THE IMPLANT ON TOOTH SITE #19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566396 IMP TM 6.0MM MTX FULL, 10 DENTAL IMPLANT DZE ZIMMER DENTAL TMT6B10 1221504 00889024018969

    Patients

    Seq Age Sex Outcome Treatment
    1