BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE

    MDR report key: 18957760 · Received March 22, 2024

    Report

    Report Number
    0002023141-2024-00891
    Event Type
    Injury
    Date Received
    March 22, 2024
    Date of Event
    September 11, 2023
    Report Date
    August 27, 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
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION. ZIMVIE DID NOT RECEIVE ONE ABUTMENT FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER, DEVICE HISTORY RECORD (DHR) REVIEW, AND RISK MANAGEMENT FILE (RMF). DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER. 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 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 PATIENT FACTORS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION COULD NOT BE VERIFIED WITHOUT DEVICE RECEIPT, THE REPORTED EVENT IS NON-VERIFIABLE. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION. FOLLOW UP WITH CUSTOMER CONFIRMED ITEM AND LOT NUMBER. G4: ADDITIONAL 510(K) NUMBERS ARE K013227 AND K953101.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4). A4: PATIENT WEIGHT IS NOT PROVIDED / UNKNOWN. D1: BRAND NAME IS NOT PROVIDED / UNKNOWN. D4: CATALOG NUMBER AND LOT NUMBER ARE NOT PROVIDED / UNKNOWN. D10: TSV4B10, IMP,TSV,4.1MM,SBM,10, LOT NUMBER 63847812. E1: INITIAL REPORTER¿S TITLE IS NOT PROVIDED / UNKNOWN.

    Description of Event or Problem · 0

    NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

    Description of Event or Problem · 0

    NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT ABUTMENT ALONGSIDE THE RESTORATION WAS SEPARATED FROM THE IMPLANT AND AN ABUTMENT FRACTURE WAS DISCOVERED. X-RAYS ALSO CONFIRMED THAT A PIECE OF ABUTMENT WAS FRACTURED INSIDE THE IMPLANT. THE IMPLANT WAS REMOVED. TOOTH SITE #26.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2556012 ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE DENTAL ABUTMENT NHA ZIMMER DENTAL 2021120242 00889024015210

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention DENTAL IMPLANT, SEE H10 NARRATIVE.