BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SP 3.7MM 10M M OCTAGON

    MDR report key: 11138926 · Received January 8, 2021

    Report

    Report Number
    0002023141-2021-00049
    Event Type
    Injury
    Date Received
    January 8, 2021
    Date of Event
    July 3, 2020
    Report Date
    April 6, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024017184
    PMA / PMN Number
    K082639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). D1: BRAND NAME UNKNOWN / NOT PROVIDED. D4: EXPIRATION DATE UPDATED TO UNKNOWN. D9: DEVICE AVAILABLE FOR EVALUATION CHANGE ¿NO' TO 'YES'. G4: PMA/510(K) NUMBER: K011245 AND K002188.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. PREMARKET IDENTIFICATION PMA/510(K) NUMBER K011245 AND K002188. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 7 WAS REMOVED DUE TO PERI-IMPLANTITIS. ADDITIONAL APPOINTMENT REQUIRED: YES, TO PLACE A NEW IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38885 IMPL TAPERED SP 3.7MM 10M M OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL SPB12 2019110768 00889024017184

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention