BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 4.1MM MTX FULL,10M

    MDR report key: 18873514 · Received March 11, 2024

    Report

    Report Number
    0002023141-2024-00662
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    July 14, 2022
    Report Date
    August 12, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024018938
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE DID NOT RECEIVE ONE (1) TMT4B10, (IMP TM 4.1MM MTX FULL,10M) 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). FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1242775. 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 1242775 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿ALLERGIC REACTION¿. THE CUSTOMER DID SUBMIT ONE (1) IMAGE FOR THE REPORTED EVENT. (SEE ATTACHMENTS TAB AT CE LEVEL). IFU REVIEW: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE ¿ TAPERED SCREW-VENT® AND TRABECULAR METAL¿ IMPLANTS - 4869 REV.10-03/24. INFORMATION IDENTIFIED: "ADVERSE EFFECTS". BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RMF RM-00541-HAZ REV. 4, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION IS EXTERNAL FACTORS (I.E. PATIENT CONDITIONS.) 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 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. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP." H3: CHANGED "YES" TO "NO". H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE. H3 OTHER TEXT: DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. E1: PHONE NUMBER (B)(6). G4: PMA/510(K) NUMBER K113753, K112160.

    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 ALLERGIC REACTION. TOOTH SITE # 45.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710944 IMP TM 4.1MM MTX FULL,10M DENTAL IMPLANT DZE ZIMMER DENTAL 1242775 00889024018938

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention