BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,10,MTX,MG

    MDR report key: 18295214 · Received December 8, 2023

    Report

    Report Number
    0002023141-2023-03527
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Report Date
    February 21, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019997
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). B3: DATE OF EVENT UNKNOWN / NOT PROVIDED D6A: IMPLANT DATE UNKNOWN / NOT PROVIDED D6B: EXPLANT DATE UNKNOWN / NOT PROVIDED G4: K101880.

    Additional Manufacturer Narrative · 0

    ZIMVIE DID NOT RECEIVE ONE (1) TSVTWB10, (IMP,TSV,4.7,10,MTX,MG) AND ONE (1) TSVM4B11 (IMP,TSV,MCOL MG,4.1MM,11.5MML) 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). THIS COMPLAINT REFERS TO THE TSVTWB10. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1253642. 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 1253642 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 WAS MISSING OR CONFUSING INSTRUCTIONS FOR USE OR THE TORQUE APPLIED DURING PLACEMENT/SEATING EXCEEDED RECOMMENDED VALUE. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION WAS NOT ESTABLISHED. 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. 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN PLACING THE IMPLANT IN SITE 31 BUT THE MOUNT WOULD NOT DISENGAGE WITHOUT IMPLANT COMING WITH IT. TRIED TWICE AND THIRD IMPLANT WAS ABLE TO BE PLACED AND MOUNT REMOVED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262498 IMP,TSV,4.7,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1253642 00889024019997

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male