BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    MDR report key: 17034847 · Received May 31, 2023

    Report

    Report Number
    0002023141-2023-01517
    Event Type
    Injury
    Date Received
    May 31, 2023
    Date of Event
    December 28, 2022
    Report Date
    October 30, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410
    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

    THE REPORTED IMPLANT (TSVB10) WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, VISUAL EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION WAS CONDUCTED USING APPLICABLE INSTRUCTIONS FOR USE, RISK FILES AND OTHER AVAILABLE INFORMATION. DHR REVIEW FOR THE LOT (1244048) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMVIE. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT (1244048) AND 1 SIMILAR EVENT OR COMPLAINT WAS FOUND (B)(4). (COMPLAINT CATEGORY KEYWORD: FRACTURE: IMPLANT). THE CUSTOMER DID NOT SUBMIT ANY IMAGES/X-RAY. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE - TAPERED SCREW-VENT AND TRABECULAR METAL IMPLANTS, IFU4869 REV 9-10/19. INFORMATION IDENTIFIED: CONTRAINDICATIONS, PRECAUTIONS, AND ADVERSE EFFECTS. PER THE APPLICABLE IFU, IT IS STATED THAT IMPROPER TECHNIQUES, SEVERE BRUXISM, CLENCHING, AND OVERLOADING, MAY CAUSE COMPONENT FRACTURE. 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. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION AND THE REPORTED EVENT COULD NOT BE VERIFIED. 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. G4: K011028, K013227.

    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 # 20 WAS REMOVED DUE TO FRACTURE. PATIENT WAS HAVING PAIN IN IMPLANT SITE BECAUSE SHE WAS CHEWING SOME FOOD AND IT FRACTURED IMPLANTS. REQUESTED TO BE REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296955 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB10 1244048 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Prefer Not To Disclose Required Intervention