BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SP 3.7MM 10M M OCTAGON

    MDR report key: 10769860 · Received November 2, 2020

    Report

    Report Number
    0002023141-2020-01861
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    April 29, 2019
    Report Date
    December 4, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024017177
    PMA / PMN Number
    K082639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4), INVESTIGATION / RESULTS ONE UNKNOWN ZIMMER BIOMET SCREW AND SWISSPLUS IMPLANT WERE NOT RETURNED FOR INVESTIGATION. THEREFORE, VISUAL EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION WAS PERFORMED USING APPLICABLE INSTRUCTIONS FOR USE AND RISK FILES. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE PRODUCTS WERE NOT RETURNED. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE LOT (63527918) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. HOWEVER, DHR REVIEW COULD NOT BE PERFORMED FOR THE SCREW AS THE LOT NUMBER WAS UNKNOWN. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT (63527918) AND NO SIMILAR EVENT OR COMPLAINT WAS FOUND. HOWEVER, COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED FOR THE SCREW AS THE ITEM/LOT NUMBER WAS UNKNOWN. BASED ON THE AVAILABLE INFORMATION DEVICE MALFUNCTION AND THE REPORTED EVENT COULD NOT BE VERIFIED SINCE THE PRODUCTS WERE NOT RETURNED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PREMARKET IDENTIFICATION PMA/510(K) NUMBER K011245 AND K002188.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR PLACED AN SPB10 IMPLANT AND USED THE IMPLANT MOUNT TO CREATE A CEMENT RETAINED RESTORATION. THE ABUTMENT SCREW GOT LOOSE AND DOCTOR HAD TO DRILL THE CROWN TO ACCESS TO THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236180 IMPL TAPERED SP 3.7MM 10M M OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL SPB10 63527918 00889024017177

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR