BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,6.0,10,MTX,MG

    MDR report key: 16504747 · Received March 8, 2023

    Report

    Report Number
    0002023141-2023-00755
    Event Type
    Injury
    Date Received
    March 8, 2023
    Report Date
    October 17, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019874
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) TSVT6B10, (IMP, TSV,6.0,10, MTX, MG) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE. DEVICE WAS MEASURED WITH A CALIPER (CAL002C159 CAL DUE: JUN 7, 2023) AND MATCHED PRINT SPECIFICATIONS. NO MALFUNCTION WAS IDENTIFIED THAT COULD LEAD TO THE REPORTED EVENTS. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. A PRE-EXISTING CONDITION NOTED ON THE PER WAS LOW BONE DENSITY (TYPE III). THE REPORTED DEVICE WAS LOCATED ON TOOTH # 14 (UNIVERSAL) AND WAS USED FOR APPROXIMATELY 1 MONTH, 13 DAYS. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1250935. 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 1250935 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿PERFORATED SINUS¿ & ¿INFECTION.¿ THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. IFU REVIEW: DOCUMENTS REVIEWED: ¿INSTRUCTIONS FOR USE FOR TAPERED SCREW-VENT®, ADVENT® AND TRABECULAR METAL¿ IMPLANTS¿ 4869 REV. 9-10/19. INFORMATION IDENTIFIED: "PRECAUTIONS" "WARNINGS¿ ¿ADVERSE EFFECTS.¿ BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RMF RM-00541-HAZ REV. 3, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE BACTERIAL INFECTION, CLINICIAN PLACES IMPLANT IN A PATIENT WITH PATIENT FACTORS (E.G., POOR BONE QUALITY, POOR PATIENT HYGIENE, PERIODONTAL ISSUES, PREEXISTING MEDICAL CONDITIONS) INCOMPATIBLE WITH OSSEOINTEGRATION OF IMPLANT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR, AND THE REPORTED EVENTS WERE NON-VERIFIABLE WITH THE INFORMATION PROVIDED. 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 "NO" TO "YES."

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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 IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO A PERFORATED SINUS. SYMPTOMS OF THE EVENT: PAIN AND ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163469 IMP,TSV,6.0,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVT6B10 1250935 00889024019874

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Prefer Not To Disclose Required Intervention