BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 4.1MM MTX,13MM

    MDR report key: 19100137 · Received April 12, 2024

    Report

    Report Number
    0002023141-2024-01163
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    March 13, 2024
    Report Date
    September 16, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018822
    PMA / PMN Number
    K132258
    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). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION: K113753/K112160.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER CMP (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. IT WAS REPORTED AN IMPLANT FRACTURED AT THE BOTTOM DURING SURGICAL PROCEDURE AT TOOTH SITE #15 APPLYING NORMAL TORQUE. PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT. BOTH PARTS OF THE IMPLANT WERE REMOVED. PATIENT SUFFERED ONE (1) HOUR DELAY AT THE TREATMENT. ZIMVIE RECEIVED ONE (1) TMM4B13, (IMP TM 4.1MM MTX,13MM) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE AND WAS ATTACHED TO ITS BUNDLE MOUNT. THE IMPLANT WAS FRACTURED AT THE BOTTOM PART. THE REMAINING FRACTURED PART WAS RETURNED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1232412. 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 1232412 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: FRACTURE IMPLANT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION IS EXCESSIVE TORQUE APPLIED DURING PLACEMENT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE REPORTED EVENT WAS CONFIRMED WITH ALL THE AVAILABLE INFORMATION. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS 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

    IT WAS REPORTED AN IMPLANT FRACTURED AT THE BOTTOM DURING SURGICAL PROCEDURE AT TOOTH SITE #15 APPLYING NORMAL TORQUE. PROCEDURE WAS COMPLETE WITH ANOTHER IMPLANT. BOTH PARTS OF THE IMPLANT WERE REMOVED. PATIENT SUFFERED 1 HOUR DELAY AT THE TREATMENT.

    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
    836368 IMP TM 4.1MM MTX,13MM DENTAL IMPLANT DZE ZIMMER DENTAL 1232412 00889024018822

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male