BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE

    MDR report key: 19231215 · Received May 2, 2024

    Report

    Report Number
    0002023141-2024-01417
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    March 7, 2023
    Report Date
    September 19, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    NHA
    UDI-DI
    00889024015210
    PMA / PMN Number
    K011028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). D10: TSVWB10, IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM/LOT#: 1220488. G4: ADDITIONAL PMA/510(K) NUMBER ¿K013227/K953101. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. D9: DEVICE AVAILABILITY AND RETURN DATE WERE UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: TYPE OF INVESTIGATION CODES WERE ADDED: 4109, 4111 AND 3331. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 3252. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 4307. H10: NARRATIVE/DATA WAS UPDATED. ZIMVIE RECEIVED THE REPORTED ABUTMENT/SCREW FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, A FRACTURED SCREW AND ABUTMENT HEX WAS IDENTIFIED INSIDE IMPLANT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2018071278. 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 2018071278 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS THE PRODUCT WAS SUBJECTED TO OCCLUSAL LOADING. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR. THERE WAS FRACTURED SCREW AND ABUTMENT HEX IDENTIFIED INSIDE IMPLANT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 HAD TO BE REMOVED AS THE CROWN WAS LOOSE DUE TO THE ABUTMENT SCREW FRACTURING. THE IMPLANT WAS REMOVED AFTER TRYING TO REMOVE THE FRACTURED SCREW AND NOT BEING ABLE TO. THE SURGERY WAS COMPLETED WITH ANOTHER IMPLANT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857443 ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE DENTAL SCREW NHA ZIMMER DENTAL 2018071278 00889024015210

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention DENTAL IMPLANT.