BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,11.5

    MDR report key: 18767417 · Received February 23, 2024

    Report

    Report Number
    0002023141-2024-00452
    Event Type
    Injury
    Date Received
    February 23, 2024
    Date of Event
    January 27, 2023
    Report Date
    August 26, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019232
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). E1: REPORTER ADDRESS: FRESDENTAL INNOVACION Y MANUFACTURAS, S.L./POL. IND LES GALGUES/CL. VINATERS, 3.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. D4: ADDITIONAL DEVICE INFORMATION. D9: DEVICE AVAILABILITY. G3: DATE RECEIVED BY MANUFACTURER. G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H4: DEVICE MANUFACTURER DATE. H6: ADVERSE EVENT PROBLEM. H10: ADDITIONAL NARRATIVE. ZIMVIE RECEIVED ONE (1) TSV4B11, (IMP,TSV,4.1MM,SBM,11.5) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, DAMAGE TO THE IMPLANT WAS IDENTIFIED. THE IMPLANT HAD BONE DEBRIS ON ITS EXTERNAL THREADS. THE IMPLANT WAS FRACTURED AT THE COLLAR. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1250413. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1250413 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL : MEDICAL : BONE LOSS AND DENTAL : FUNCTIONAL : FRACTURE : IMPLANT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS THE CLINICIAN SELECTS IMPLANT THAT IS UNABLE TO RESIST LONG-TERM OCCLUSAL LOADING. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE IMPLANTS COLLAR WAS FRACTURED. THE REPORTED EVENT WAS CONFIRMED. HOWEVER, THE BONE LOSS EVENT IS NON-VERIFIABLE WITH ALL THE INFORMATION. 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. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.

    Description of Event or Problem · 0

    THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #26 FAILED BECAUSE IT FRACTURED AT THE HEAD. THE DOCTOR REPORTS THAT THE PROCEDURE WAS CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: III THE DOCTOR REPORTED: BONE LOSS.

    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
    128838 IMP,TSV,4.1MM,SBM,11.5 DENTAL IMPLANT DZE ZIMMER DENTAL 1250413 00889024019232

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male