BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V HA 6MM 5.7MM 11.5MM

    MDR report key: 21631454 · Received March 18, 2025

    Report

    Report Number
    0002023141-2025-00727
    Event Type
    Injury
    Date Received
    March 18, 2025
    Date of Event
    July 18, 2024
    Report Date
    June 24, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019461
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED . E1: LAST NAME UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER K013227.

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) TSV6H11, (IMPL TAPERED SCR-V HA 6 MM 5.7 MM 11.5 MM) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE, APPARENT MINOR BONE/TISSUE ATTACHED TO EXTERNAL THREADS. THE IMPLANT WAS IDENTIFIED AS REPORTED HOWEVER, NO APPARENT MALFUNCTION WAS IDENTIFIED WITH THE IMPLANT THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. IMPLANT MATCHED PRINTS WHERE MEASURED. 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 1260108. 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 1260108 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: "PAIN". THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENT. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RMF RM-00541-HAZ REV. 4, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION IS INADEQUATE TREATMENT PLANNING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO PAIN. IMPLANT PLACED AND PATIENT RETURNED 4 DAYS LATER WITH PAIN AND TINGLING. PATIENT HAS SOME SENSATION INTRA AND EXTRA ORALLY. DISCUSSED WITH PATIENT THAT COULD JUST BE FROM INFLAMMATION COMPRESSING ON THE NERVE. DISCUSSED LEAVING THE IMPLANT FOR A FEW DAYS TO SEE IF THERE IS ANY IMPROVEMENT. PATIENT CHOSE TO REMOVE IMPLANT DUE TO PAIN. REMOVED IMPLANT AND PLACED PUROS GRAFT. UPON REMOVAL, NOTED THERE WAS A BONY FLOOR AND INFERIOR ALVEOLAR NERVE WAS NOT EXPOSED. PATIENT HAS NOT RETURNED FOR IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373284 IMPL TAPERED SCR-V HA 6MM 5.7MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 1260108 00889024019461

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention