BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

    MDR report key: 17303321 · Received July 11, 2023

    Report

    Report Number
    0002023141-2023-01864
    Event Type
    Injury
    Date Received
    July 11, 2023
    Date of Event
    April 25, 2023
    Report Date
    December 27, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019515
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) TSVB11, (IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE, NO APPARENT MALFUNCTION WAS IDENTIFIED WITH THE IMPLANT THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. PRODUCT WITHIN SPECIFICATION. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1250957. 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 1250957 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. IFU REVIEW: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE ¿ TAPERED SCREW-VENT® AND TRABECULAR METAL¿ IMPLANTS - 4869 REV. 9-10/19. INFORMATION IDENTIFIED: "ADVERSE EFFECTS" PAGE 2. 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 MISSING OR CONFUSING INSTRUCTIONS FOR USE, MATERIAL SELECTION. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID NOT OCCUR. THE REPORTED EVENT WAS NON-VERIFIABLE WITH ALL THE AVAILABLE INFORMATION. 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.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. G4: 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 THERE WAS AN ALLERGIC REACTION. THE PATIENT CAME TO THE CLINIC DUE TO THE MISSING TOOTH OF LEFT UPPER 5 IN (B)(6) 2023. THE IMPLANTATION WAS PERFORMED AFTER EXAMINATION. THE ZIMMER TSV IMPLANT OF 3.7*11.5 WAS IMPLANTED. THE PATIENT REFLECTED THE PAIN AT THE IMPLANT SITE AND CAME TO THE CLINIC FOR EXAMINATION. THE ALLERGY WAS FOUND. THE IMPLANT WAS THEN REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA. TOOTH SITE # 25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240347 IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB11 1250957 00889024019515

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female