BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,MCOL MG,3.7MM,10M

    MDR report key: 18741654 · Received February 20, 2024

    Report

    Report Number
    0002023141-2024-00388
    Event Type
    Injury
    Date Received
    February 20, 2024
    Date of Event
    January 16, 2024
    Report Date
    July 29, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K111889
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). ZIMVIE DID NOT RECEIVED ONE (1) TSVMB10, (IMPLANT, TSV, 3.7MMD, 10MML, TEXTURED, MICROGROOVES, MC) 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 1243209. 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 1243209 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL : FUNCTIONAL : FRACTURE : IMPLANT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS LONG-TERM PARAFUNCTIONAL HABITS (E.G., CLENCHING, BRUXISM, AND OVERLOADING) OF THE PATIENT OVER THE IMPLANTATION PERIOD ¿ PATIENT FACTORS. THEREFORE, BASED ON THE X-RAY IMAGES SUBMITTED BY THE CUSTOMER, DEVICE MALFUNCTION DID OCCUR. A FRACTURE IS CLEARLY VISIBLE AROUND THE IMPLANT COLLAR. THE REPORTED EVENT IS CONFIRMED. 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. 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.

    Additional Manufacturer Narrative · 0

    ZIMVIE (B)(4).

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE PATIENT CAME TO MEDICAL OFFICE FOR A REGULAR CHECK UP WITH DISCOMFORM AT THE CROW. IT WAS NOTICED, AN IMPORTANT MOBILITY OF THE CROWN. DOCTOR REMOVED THE COMPOSITE TO BE ABLE TO ACCESS TO THE SCREW, BUT THE SCREW CAME OUT. AFTER UNSCREWING THE CROWN, IT HAS BEEN IDENTIFIED, THAT THE IMPLANT COLLAR WAS FRACTURED AT DISTAL. IMPLANT WOULD NEED TO BE REMOVED. AND NEW IMPLANT PLACED. BONE TYPE I. TOOTH LOCATION 36.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396805 IMP,TSV,MCOL MG,3.7MM,10M DENTAL IMPLANT DZE ZIMMER DENTAL 1243209

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female