BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,10,MTX,MG

    MDR report key: 20932477 · Received December 14, 2024

    Report

    Report Number
    0002023141-2024-04022
    Event Type
    Injury
    Date Received
    December 14, 2024
    Date of Event
    June 24, 2024
    Report Date
    March 27, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019997
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. D10. CONCOMITANT MEDICAL PRODUCTS TSVTWB10, IMP,TSV,4.7,10,MTX,MG, LOT 1250489. G4: PREMARKET IDENTIFICATION K101880.

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) TSVTWB10, (IMP,TSV,4.7,10,MTX,MG), FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, A FRACTURE HAS BEEN IDENTIFIED ON THE IMPLANTS COLLAR. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1250489. 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 1250489, FOR SIMILAR EVENTS AND ONE OTHER COMPLAINT (B)(4) WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL : FUNCTIONAL : FRACTURE : IMPLANT¿. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RM-00541-HAZ, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS CLINICIAN SELECTS IMPLANT THAT IS UNABLE TO RESIST LONG-TERM OCCLUSAL LOADING. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE FRACTURE HAS BEEN IDENTIFIED ON THE COLLAR. THE REPORTED EVENT WAS CONFIRMED. 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: CHANGED "NO" TO "YES". H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED PATIENT CAME IN (B)(6) 2024, STATED HIS IMPLANT CROWN WERE LOOSE #19 AND #30. BOTH HAD IMPLANT COLLAR FRACTURES. REMOVED #19 AND #30 WILL BE REMOVED AT LATER DATE. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. NO DELAY DURING THE PROCEDURE. SURGICAL INTERVENTION TO REMOVE THE IMPLANT AT TOOTH SITE 19. ADDITIONAL APPOINTMENT IS REQUIRED FOR FUTURE GRAFTING AND IMPLANT PLACEMENT. NO OTHER IMPLANT WAS PLACED TO COMPLETE THE PROCEDURE. DISCOVERED DURING AN EMERGENCY VISIT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858449 IMP,TSV,4.7,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1250489 00889024019997

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male DENTAL IMPLANT SEE H10 NARRATIVE| DENTAL IMPLANT SEE H10 NARRATIVE