BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,MCOL MG,4.7MM,10M

    MDR report key: 14571862 · Received June 2, 2022

    Report

    Report Number
    0002023141-2022-01353
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    March 3, 2022
    Report Date
    October 14, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019775
    PMA / PMN Number
    K111889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PMA/510K: PREMARKET IDENTIFICATION K101880.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE IMP, TSV, MCOL MG,4.7MM,10M (TSVMWB10) AND MOUNT WERE RETURNED FOR INVESTIGATION. THERE WERE NO ALLEGATIONS AGAINST THE MOUNT AND THE REPORTED EVENT OCCURRED AT IMPLANT LEVEL. THEREFORE, THIS INVESTIGATION ADDRESSED ONLY THE IMPLANT. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE BUT NO APPARENT SIGNS OF MALFUNCTION. THE IMPLANT COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED FAILURE (PLACED IN POSITION TOO MESIAL). MEASUREMENTS WERE TAKEN ON (B)(6), 2022 USING A CALIPER. THROUGH DIMENSIONAL ANALYSIS AND COMPARISON TO DRAWINGS, THE DEVICE WAS DETERMINED TO BE WITHIN DESIGN SPECIFICATIONS WHEN IT LEFT ZIMVIE. DEVICE HISTORY RECORD (DHR) REVIEW FOR THE LOT (1243376) 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. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1243376) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FUNCTIONAL: OTHER (PLACED IN POSITION TOO MESIAL) AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND DIMENSIONAL ANALYSIS, DEVICE MALFUNCTION DID NOT OCCUR. ADDITIONALLY, THE REPORTED EVENT COULD NOT BE VERIFIED.

    Description of Event or Problem · 0

    THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #47 FAILED BECAUSE ITS PLACEMENT WAS TOO MESIAL, THE DOCTOR REMOVED THE IMPLANT AND PLACED ANOTHER ONE MORE DISTAL. THE DOCTOR REPORTS THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH AS A RESULT OF THE EVENT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184870 IMP,TSV,MCOL MG,4.7MM,10M DENTAL IMPLANT DZE ZIMMER DENTAL TSVMWB10 1243376 00889024019775

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention