BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,8,MTX,MG

    MDR report key: 20641478 · Received November 8, 2024

    Report

    Report Number
    0002023141-2024-03581
    Event Type
    Injury
    Date Received
    November 8, 2024
    Date of Event
    March 14, 2024
    Report Date
    November 7, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020030
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). . G4: ADDITIONAL PMA/510(K) NUMBER K101977/K101880 A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR BONE LOSS EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. PREVIOUSLY COMPLETED INVESTIGATIONS FOR BONE LOSS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO BONE LOSS AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT REPORTED TO OFFICE 5 YEARS LATER AFTER IMPLANT WAS PLACED REPORTING MOVEMENT WHEN CHEWING. DID NOT HAVE PAIN DUE TO NOT HAVING FEELING IN THAT AREA REGARDLESS. UPON FINDINGS DAY OF FOLLOW-UP, CROWN & IMPLANT FELL OUT W/NO FORCE. PER INDICATED: SYMPTOMS AS A RESULT OF THE EVENT: EDEMA, INFLAMMATION. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. WAS THERE A DELAY DURING THE PROCEDURE: NO. ADDITIONAL APPOINTMENT REQUIRED: NO. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905131 IMP,TSV,4.7,8,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1223585 00889024020030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention