BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 4.7MM MTX FULL, 11.5MM

    MDR report key: 19621717 · Received June 27, 2024

    Report

    Report Number
    0002023141-2024-02154
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    April 11, 2024
    Report Date
    June 27, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019041
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER CMP (B)(4) A4: WEIGHT UNKNOWN / NOT PROVIDED D4: LOT NUMBER UNKNOWN / NOT PROVIDED D4: UDI NOT AVAILABLE G4: PMA/510(K) NUMBER: K132258, K113753 AND K112160 A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR PERI-IMPLANTITIS 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 THESE EVENTS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF A MANUFACTURING OR DESIGN DEFECT THAT MIGHT LEAD TO PERI-IMPLANTITIS OCCURRING 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.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: A1 PATIENT IDENTIFIER . A2: AGE . A3: PATIENT SEX . B3: DATE OF EVENT. D4: CATALOG AND LOT NUMBER . D4: UDI . D6: IMPLANT DATE. D6: EXPLANT DATE. G4: PMA/510(K) NUMBER: K132258, K113753 AND K112160. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR PERI-IMPLANTITIS 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 THESE EVENTS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF A MANUFACTURING OR DESIGN DEFECT THAT MIGHT LEAD TO PERI-IMPLANTITIS OCCURRING 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. H3 OTHER TEXT : SUMMARY INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH 26 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT WOULD HAVE TO RETURN TO PLACE A NEW IMPLANT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH 26 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT WOULD HAVE TO RETURN TO PLACE A NEW IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1752540 IMP TM 4.7MM MTX FULL, 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 63232556 00889024019041

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female