BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18997541 · Received March 28, 2024

    Report

    Report Number
    0002023141-2024-00969
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    February 26, 2024
    Report Date
    August 28, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE RECEIVED ONE (1) TSVH10, (IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM) FOR EVALUATION. A VISUAL EVALUATION WAS PERFORMED, THE RETURNED IMPLANT PACKAGING WAS IDENTIFIED AS REPORTED. THE OUTER VIAL'S GREEN CAP WAS SEEN BROKEN / DAMAGED. THE OUTER VIAL'S TAMPER SEAL / RING WAS IN A SEALED CONDITION. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1261214. 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 1261214 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL : PACKAGING : DAMAGED¿ THE CUSTOMER DID SUBMIT IMAGES FOR THE REPORTED EVENT. THE IMAGES SHOWED THE IMPLANT OUTER VIALS GREEN CAP WAS CRACKED. BASED ON THE INVESTIGATION AND ACCORDING TO THE CAPA, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS INADEQUATE DESIGN OF CAP AND VIAL SYSTEM. THIS IS AN ONGOING ISSUE WHICH IS CURRENTLY BEING MONITORED. (B)(4) (PBG) AND (B)(4) (VLC), HHED-2023-00023 / HHE-2023-00021 AND CAPA-000227-2024 HAVE BEEN OPENED TO FURTHER CONTAIN AFFECTED PRODUCTS, EVALUATE POTENTIAL ROOT CAUSES, AND CONSIDER APPLICABLE CORRECTIVE ACTIONS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A PACKAGING MALFUNCTION DID OCCUR. THE IMPLANTS GREEN CAP WAS CRACKED WHILE THE GREEN CAPS TAMPER SEAL WAS INTACT. THE REPORTED EVENT/COOB WAS CONFIRMED. 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: B4: DATE OF THIS REPORT. D9: DEVICE AVAILABILITY . G3: DATE RECEIVED BY MANUFACTURER. G6: CHECKED "FOLLOW-UP". H2: CHECKED FOLLOW-UP TYPE. H3: CHANGED "NO" TO "YES". H6: ENTERED EVALUATION CODES. H10: ADDED MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). 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 CRACKED LID. WHEN THE DOCTOR OPENED THE OUTER CASE, THE GREEN LID OF THE INNER VIAL CASE WAS BROKEN. NOT OPENED. ALREADY COMPATIBLE WITH ANOTHER SIMILAR PRODUCT. IT IS NOT DAMAGE THAT WOULD OCCUR DURING SHIPPING, AND HE WOULD LIKE TO INVESTIGATE AND ANSWER THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454896 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 1261214

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female