BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

    MDR report key: 19214899 · Received April 30, 2024

    Report

    Report Number
    0002023141-2024-01390
    Event Type
    Injury
    Date Received
    April 30, 2024
    Report Date
    August 18, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019515
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A2: AGE AT TIME OF EVENT UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. B3: DATE OF EVENT UNKNOWN / NOT PROVIDED. D6: IMPLANT DATE UNKNOWN / NOT PROVIDED. D9: DEVICE AVAILABILITY UNKNOWN / NOT PROVIDED. D10: CONCOMITANT MEDICAL PRODUCT AND THERAPY DATES: TSVWB11, IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM, LOT NUMBER: 1230281. G4: PREMARKET IDENTIFICATION: K013227.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. G3: DATE RECEIVED BY MANUFACTURER. G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: ADVERSE EVENT PROBLEM. H10: ADDITIONAL NARRATIVE. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1233148. 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 1233148, FOR SIMILAR EVENTS AND ONE OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL : MEDICAL : BONE LOSS. 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

    THIS COMPLAINT REFERS TO THE TREATMENT MENTIONED IN (B)(4): DOCTOR REPORTED MASSIVE BONE LOSS WITH INFLAMMATION AT TOOTH SITES 16 AND 15. DOCTOR NOTICED IT FOR A YEAR AND TRIED TO DO THERAPY WITHOUT ANY SUCCESS. PATIENT REFERRED PAIN.

    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
    147722 IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 1233148 00889024019515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male DENTAL IMPLANT.