BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

    MDR report key: 17867361 · Received October 4, 2023

    Report

    Report Number
    0002023141-2023-02748
    Event Type
    Injury
    Date Received
    October 4, 2023
    Date of Event
    August 27, 2023
    Report Date
    March 26, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019546
    PMA / PMN Number
    K061410
    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

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. E1: REPORTER LAST NAME UNKNOWN / NOT PROVIDED. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR INFECTION EVENTS IDENTIFYING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO THE WIDE RANGE OF EXTERNAL (NON-DESIGN/ NON-MANUFACTURING RELATED) FACTORS POTENTIALLY IMPACTING THE STERILITY OF THE IMPLANT AND ITS ENVIRONMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED. H3 OTHER TEXT : SUMMARY INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED DATA AND ADDITIONAL INFORMATION. CORRECTION: CATALOG NUMBER WAS UPDATED FROM 'TSVTB8' TO 'TSVB8', BRAND NAME WAS UPDATED FROM 'IMP,TSV,3.7,8,MTX,MG' TO 'IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM', AND PMA/510(K) NUMBER FROM 'K101977' TO 'K061410 / K011028 / K013227'. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. D1: BRAND NAME WAS CORRECTED. D4: CATALOG NUMBER WAS CORRECTED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G4: ADDITIONAL PMA/510(K) NUMBER INCLUDED K011028 / K013227. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H10: NARRATIVE/DATA WAS UPDATED. H11: CORRECTED DATA WAS UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT IMPLANT TOOTH SITE #21, WITH ASSOCIATED INFLAMMATION. THEREFORE, THE IMPLANT WAS REMOVED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117425 IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL 1254941 00889024019546

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention