BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,10,MTX,MG

    MDR report key: 18585209 · Received January 25, 2024

    Report

    Report Number
    0002023141-2024-00163
    Event Type
    Injury
    Date Received
    January 25, 2024
    Date of Event
    January 11, 2023
    Report Date
    June 10, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019997
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. D3: MANUFACTURER EMAIL ADDRESS. D9: DEVICE AVAILABILITY. G1: CONTACT OFFICE (AND MANUFACTURING SITE FOR DEVICES) CONTACT NAME AND EMAIL . G3: DATE RECEIVED BY MANUFACTURER. G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H10: ADDITIONAL NARRATIVE. ZIMVIE RECEIVED ONE (1) TSVTWB10, (IMP,TSV,4.7,10,MTX,MG) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICES IDENTIFIED THE IMPLANT & ITS BUNDLE MOUNT WITH SIGNS OF USE, APPARENT DRIED BLOOD AND DEBRIS ON THE IMPLANT'S EXTERNAL THREADS. THE IMPLANT AND MOUNT DISENGAGED AND ENGAGED AS INTENDED. NO DAMAGE IDENTIFIED OR SIGNS OF MALFUNCTION THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENTS. MEASUREMENTS MATCH DRAWING. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1251868. 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 1251868 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DOES NOT DISENGAGE/RELEASE¿ & "PERFORATED SINUS THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENTS. IFU REVIEW: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE ¿ TAPERED SCREW-VENT® AND TRABECULAR. METAL¿ IMPLANTS - 4869 REV. 9-10/19. INFORMATION IDENTIFIED: BREAKAGE" & "ADVERSE EFFECTS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED SINCE DEVICE MALFUNCTION DID NOT OCCUR, AND THE REPORTED EVENT (DOES NOT DISENGAGE/RELEASE) HAS BEEN UNCONFIRMED FOLLOWING FUNCTIONAL TESTING AND PHYSICAL EVALUATION. BASED ON THE INVESTIGATION FOR THE REPORTED EVENT (PERFORATED SINUS) 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, A DEVICE MALFUNCTION DID NOT OCCUR. THE REPORTED EVENT (DOES NOT DISENGAGE/RELEASE) WAS UNCONFIRMED WITH ALL THE AVAILABLE INFORMATION. ADDITIONALLY, THE REPORTED EVENT (PERFORATED SINUS) IS 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.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). G4: ADDITIONAL PMA/510(K) NUMBER ¿ K101880. 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 IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED AT IMPLANT PLACEMENT THE TOP PART/SCREW WAS STUCK (CAPTURED IN (B)(4)TRIED TO REMOVE THE SCREW BUT IT CAME OUT WITH IMPLANT. THE OSTEOTOMY WAS WIDENED AND HAD TO REPLACE WITH ANOTHER IMPLANT. THE PATIENT EXPERIENCED SINUS PERFORATION AT TWO UNKNOWN IMPLANT TOOTH SITES; HOWEVER, ONLY 1 IMPLANT WAS RETURNED TO MANUFACTURER BECAUSE THE OTHER ONE WAS DISCARDED (DISCARDED IMPLANT CASE CAPTURED IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897870 IMP,TSV,4.7,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1251868 00889024019997

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention