BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 16MM

    MDR report key: 17434056 · Received August 1, 2023

    Report

    Report Number
    0002023141-2023-02097
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    June 5, 2023
    Report Date
    January 15, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019539
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: H6: TYPE OF INVESTIGATION CODES WERE ADDED: 4109, 4111 AND 3331. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 67. THE REPORTED IMPLANT WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED NO APPARENT SIGNS OF MALFUNCTION. DHR REVIEW FOR THE LOT (1231102) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMVIE. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT (1231102) AND NO SIMILAR EVENT OR COMPLAINT WAS FOUND. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM WAS INCORRECT TECHNIQUE USED DURING PLACEMENT OR PATIENT FACTORS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS NOT OCCURRED. THE REPORTED EVENTS COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT WERE UNKNOWN. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER - (B)(6). A4: WEIGHT UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER ¿ K011028 / K013227. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LACK OF STABILITY AFTER IMPLANTATION AT THE IMPLANT SITE AT TOOTH LOCATION #6. THE IMPLANT WAS REMOVED AND THE INCISION WAS SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697624 IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 16MM DENTAL IMPLANT DZE ZIMMER DENTAL 1231102 00889024019539

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Required Intervention