BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,13

    MDR report key: 17034942 · Received May 31, 2023

    Report

    Report Number
    0002023141-2023-01521
    Event Type
    Injury
    Date Received
    May 31, 2023
    Date of Event
    June 2, 2021
    Report Date
    November 6, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO TAPERED SCREW-VENT IMPLANTS, (TSV4B13 & TSVWB11) WERE REPORTED BUT NOT RETURNED FOR INVESTIGATION. THEREFORE, VISUAL EVALUATION COULD NOT BE PERFORMED. THIS INVESTIGATION ADDRESSES THE TSV4B13. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1242291. 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 1242291 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿ALLERGIC REACTION.¿ THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE ¿ TAPERED SCREW-VENT® AND TRABECULAR METAL¿ IMPLANTS, IFU4869 REV 9 - 10/19. INFORMATION IDENTIFIED: ADVERSE EFFECTS. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS CUSTOMER ERROR/PATIENT FACTOR. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION AND THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT WERE UNKNOWN/UNVERIFIABLE. 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: G6: CHECKED "FOLLOW-UP." H3: CHANGED "YES" TO "NO."

    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 THE IMPLANTS AT TOOTH SITES # 14 WERE REMOVED DUE TO AN ALLERGIC REACTION. PATIENT HAS AN ALLERGIC REACTION AND HAS BIG INFLAMMATION. PATIENT REQUESTED IMPLANTS TO BE REMOVED. CUSTOMER REPORTED THAT NO ALLERGY TEST WAS DONE. THE PATIENT HAD AN ALLERGIC REACTION BUMPS/HIVES THAT CONFIRMED ALLERGY. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682950 IMP,TSV,4.1MM,SBM,13 DENTAL IMPLANT DZE ZIMMER DENTAL 1242291

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Prefer Not To Disclose Required Intervention