BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.1MM,SBM,8

    MDR report key: 16825271 · Received April 27, 2023

    Report

    Report Number
    0002023141-2023-01188
    Event Type
    Malfunction
    Date Received
    April 27, 2023
    Date of Event
    March 15, 2023
    Report Date
    October 9, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019263
    PMA / PMN Number
    K072589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT WHEN THE BOX WAS OPENED FOR IMPLANT PLACEMENT, IT WAS EMPTY, THE IMPLANT AND THE MOUNT WERE MISSING. ZIMVIE DID RECEIVE PACKAGING VIALS WITH BROKEN SEAL HOWEVER DID NOT RECEIVE ONE (1) TSV4B8, (IMP,TSV,4.1MM,SBM,8) 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 1253107. 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 1253107 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DENTAL : PACKAGING : INCORRECT COMPONENT QUANTITY THE CUSTOMER DID/DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER PFMECA # 30, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS INCORRECT PROCESS FOLLOWED. 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. 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: .

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE SURGERY, WHEN THE BOX WAS OPENED FOR IMPLANT PLACEMENT, IT WAS EMPTY, THE IMPLANT AND THE MOUNT WERE MISSING. ANOTHER IMPLANT HAS BEEN PLACED IN ORDER TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747030 IMP,TSV,4.1MM,SBM,8 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B8 1253107 00889024019263

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Prefer Not To Disclose