BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY ANGLED ABUTMENT

    MDR report key: 9975354 · Received April 17, 2020

    Report

    Report Number
    3001617766-2020-02526
    Event Type
    Malfunction
    Date Received
    April 17, 2020
    Date of Event
    April 30, 2019
    Report Date
    April 17, 2020
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    NHA
    UDI-DI
    10841307110712
    PMA / PMN Number
    K090234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE INVESTIGATION WAS PERFORMED, AND ALLEGATIONS REPORTED BY THE CUSTOMER WERE DEEMED TO BE FALSE. PART NUMBER 8530-51 WAS NOT LABELED AT THE SAME TIME AS PART NUMBER 8530-52. ALL MANUFACTURING DOCUMENTS SHOWED THAT PART NUMBER 8530-52, LOT 135550 WAS PROCESSED CORRECTLY. THE FINDINGS OF THE INVESTIGATION SUPPORT THE POSSIBILITY THAT THE CUSTOMER HAVING ORDERED THE TWO PARTS IN QUESTION, MAY HAVE OPENED THE PACKAGE OF PART NUMBER 8530-52 WITHOUT BREAKING THE SEAL AND PLACED THE CAP FOR PART NUMBER 8530-51 ON THE VIAL OF PART NUMBER 8530-52. THERE WERE NO ISSUES IDENTIFIED IN THE MANUFACTURING PROCESS. REVIEW OF THE JOB TRAVELER INDICATED THAT PART NUMBER 8530-52 LOT 135550 WAS LABELED ON 2/20/19. NO JOB FOR PART NUMBER 8530-51 WAS LABELED AROUND THIS DATE. THE CLOSEST DATE FOR LABELING OF PART NUMBER 8530-51 OCCURRED ON 04/16/2019. BASED ON THIS INVESTIGATION, IT WAS DETERMINED THAT THE PRODUCT MET ITS SPECIFICATIONS UPON RELEASE AND DID NOT MALFUNCTION. AS A RESULT, THE EVENT WAS CLASSIFIED AS NOT REPORTABLE AND NO FURTHER CORRECTIVE ACTIONS WERE TAKEN. THIS COMPLAINT HAS SINCE BEEN RE-EVALUATED AND IS BEING FILED LATE OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    PER COMPLAINT (B)(4), IT WAS NOTICED IN THE EUROPEAN DISTRIBUTION CENTER THAT A CUSTOMER RETURNED PRODUCT FOR CREDIT [PART 8530-52, LOT 13550] HAD A CAP LABEL THAT DID NOT MATCH THE VIAL LABEL. THE CAP LABEL RETURNED WAS FOR PART NUMBER 8530-51.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438990 LEGACY ANGLED ABUTMENT DENTAL ABUTMENT NHA IMPLANT DIRECT SYBRON MANUFACTURING LLC 8530-52 135550 10841307110712

    Patients

    Seq Age Sex Outcome Treatment
    1