BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SP 3.7MM 10M M OCTAGON

    MDR report key: 17404524 · Received July 27, 2023

    Report

    Report Number
    0002023141-2023-02040
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    April 20, 2023
    Report Date
    January 28, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024017177
    PMA / PMN Number
    K082639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). A2: AGE AT TIME OF THE EVENT UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION: K082639/K011245/K002188.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ZIMVIE RECEIVED ONE (1) SPB10, (IMPL TAPERED SP 3.7MM 10M M OCTAGON) FOR EVALUATION. VISUAL EVALUATION / FUNCTIONAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE BUT NO APPARENT SIGNS OF MALFUNCTION. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2020020320. 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 2020020320 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: PAIN. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS MISSING OR CONFUSING INSTRUCTIONS FOR USE AND INADEQUATE TREATMENT PLANNING. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR, AND THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT WERE UNKNOWN/UNVERIFIABLE. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 36 WAS REMOVED DUE TO 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
    817421 IMPL TAPERED SP 3.7MM 10M M OCTAGON DENTAL IMPLANT DZE ZIMMER DENTAL 2020020320 00889024017177

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female