BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM

    MDR report key: 16765760 · Received April 18, 2023

    Report

    Report Number
    0002023141-2023-01108
    Event Type
    Injury
    Date Received
    April 18, 2023
    Date of Event
    March 14, 2023
    Report Date
    September 18, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020054
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED. EMAIL UNKNOWN / NOT PROVIDED. K013227.

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) TSVWB11, (IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM) FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, A FRACTURE HAS BEEN IDENTIFIED ON THE IMPLANTS COLLAR. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1231838. 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 1231838 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RM-00541-HAZ, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WERE MISSING OR CONFUSING INSTRUCTIONS FOR USE AND TORQUE OR SPEED APPLIED DURING PLACEMENT/SEATING EXCEEDS RECOMMENDED VALUE THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE FRACTURE HAS BEEN IDENTIFIED ON THE COLLAR. THE REPORTED EVENT WAS CONFIRMED. 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 DENTAL IMPLANT LOCATED IN POSITION NUMBER 19 FAILED BECAUSE IT FRACTURED AT THE NECK. THE DOCTOR REPORTS SWELLING AND PAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER 1 FAILED BECAUSE IT FRACTURED AT THE NECK. THE DOCTOR REPORTS SWELLING AND PAIN THE AFFECTED DENTAL POSITION IS #36.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045078 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB11 1231838 00889024020054

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Prefer Not To Disclose Required Intervention