BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL SCR-V MINI SBM 3.3MM 3.5MM 8MM

    MDR report key: 9239164 · Received October 25, 2019

    Report

    Report Number
    0002023141-2019-00970
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Report Date
    December 20, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: DATE OF REPORT, DATE RECEIVED BY MANUFACTURER, ADDITIONAL 510K NUMBERS: K011028, K013227, CHECKED "FOLLOW-UP", CHECKED FOLLOW-UP TYPE, DEVICE EVALUATION CHECKED "NO". DEVICE REMAINS IMPLANTED IN PATIENT. ENTERED EVALUATION CODES, ADDED MANUFACTURER NARRATIVE. THE REPORTED DEVICE WAS NOT RETURNED AND THE REPORTED EVENT IS CONFIRMED AS A FRACTURE WAS IDENTIFIED ON THE PROVIDED X-RAY. BASED ON THE EVALUATION, THE DEVICE MALFUNCTION HAD OCCURRED. DHR REVIEW AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE IMPLANT DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCE/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED DEVICE RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT IDENTIFIER IS NOT PROVIDED / UNKNOWN. PATIENT AGE IS NOT PROVIDED / UNKNOWN. PATIENT WEIGHT IS NOT PROVIDED / UNKNOWN. DATE OF EVENT IS NOT PROVIDED / UNKNOWN. LOT NUMBER IS NOT PROVIDED / UNKNOWN. ADDITIONAL 510(K) NUMBER IS K011028 AND K013227. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT THE IMPLANT SVMB8 WAS FRACTURED IN TWO PLACES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032531 IMPL SCR-V MINI SBM 3.3MM 3.5MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1