BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,10,MTX,MG

    MDR report key: 20932476 · Received December 14, 2024

    Report

    Report Number
    0002023141-2024-04021
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE DID NOT RECEIVE ONE (1) TSVTWB10, (IMP,TSV,4.7,10,MTX,MG) , FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER, DEVICE HISTORY RECORD (DHR) REVIEW, AND RISK MANAGEMENT FILE (RMF). 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 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 AND CLINICIAN SELECTS IMPLANT THAT IS UNABLE TO RESIST LONG-TERM OCCLUSAL LOADING. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION COULD NOT BE VERIFIED. WITHOUT DEVICE RECEIPT, THE REPORTED EVENT IS NON-VERIFIABLE. 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" H3: CHANGED "YES" TO "NO" H6: ENTERED EVALUATION CODES H10: ADDED MANUFACTURER NARRATIVE H3 OTHER TEXT : DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER: (B)(4). D9: DEVICE AVAILABILITY NO: REMAINS IMPLANTED. D10. CONCOMITANT MEDICAL PRODUCTS TSVTWB10, IMP, TSV, 4.7, 10, MTX, MG, LOT: 1250489. G4: PREMARKET IDENTIFICATION: K101880.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    CUSTOMER REPORTED PATIENT CAME IN ON (B)(6) 2024, STATED HIS IMPLANT CROWN WERE LOOSE #19 AND #30. BOTH HAD IMPLANT COLLAR FRACTURES. IMPLANT REMOVED AT TOOTH SITE #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. ON (B)(6) 2024, THE DOCTOR CONFIRMED VIA EMAIL THAT THE IMPLANT HAS NOT BEEN REMOVED, WILL NEED TO (REMOVE THE IMPLANT) IN THE NEAR FUTURE AND THE PATIENT HAS NOT BEEN SCHEDULED (FOR IMPLANT REMOVAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858448 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.