BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPRA IMPLANT SYSTEM

    MDR report key: 9678162 · Received February 6, 2020

    Report

    Report Number
    3011386779-2020-00028
    Event Type
    Injury
    Date Received
    February 6, 2020
    Date of Event
    February 4, 2020
    Report Date
    February 7, 2020
    Manufacturer
    INTEGRUM AB
    Product Code
    PJY
    UDI-DI
    07340152100443
    PMA / PMN Number
    H080004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTEGRUM WAS INFORMED 9TH OF JANUARY ABOUT FIXTURE LOOSENING (FIXTURE WILL BE REMOVED). PATIENT HAS HAD A HISTORY OF INFECTIONS AND PAIN. INFECTION WILL BE TREATED BY DEBRIDEMENT, LOCAL AND SYSTEMIC ANTIBIOTICS. FIXTURE HAS BEEN REMOVED IN SURGERY AND WILL NOT BE REPLACED. NO FURTHER INFORMATION WILL BE OBTAINED. SINCE FIXTURE WILL NOT BE RETURNED TO INTEGRUM. CORRECTION: 7TH OF FEBRUARY. SECTION D7 UPDATED WITH CORRECT EXPLANT DATE, DUE TO TYPO.

    Description of Event or Problem · 0

    9TH OF JANUARY 2020 INTEGRUM RECEIVED INFORMATION THAT PATIENT WILL REMOVE FIXTURE DUE TO FIXTURE LOOSENING. PATIENT HAS HAD A HISTORY OF INFECTIONS AND PAIN. INFECTION WILL BE TREATED BY DEBRIDEMENT, LOCAL AND SYSTEMIC ANTIBIOTICS. BATCH DOCUMENTATION REVIEWED. NO DEVIATIONS FOUND IN PRODUCT. PATIENT HAD THE IMPLANT FOR 14 YEARS AND THEREFORE THIS IS NOT CONSIDERED AN EARLY FAILURE. ON (B)(6) 2020, FIXTURE REMOVAL SURGERY PERFORMED. FIXTURE WILL NOT BE REPLACED. NO FURTHER INFORMATION WILL BE OBTAINED.

    Additional Manufacturer Narrative · 1

    INTEGRUM WAS INFORMED 9TH OF JANUARY ABOUT FIXTURE LOOSENING (FIXTURE WILL BE REMOVED). PATIENT HAS HAD A HISTORY OF INFECTIONS AND PAIN. INFECTION WILL BE TREATED BY DEBRIDEMENT, LOCAL AND SYSTEMIC ANTIBIOTICS. FIXTURE HAS BEEN REMOVED IN SURGERY AND WILL NOT BE REPLACED. NO FURTHER INFORMATION WILL BE OBTAINED. SINCE FIXTURE WILL NOT BE RETURNED TO INTEGRUM.

    Description of Event or Problem · 1

    9TH OF JANUARY 2020 INTEGRUM RECEIVED INFORMATION THAT PATIENT WILL REMOVE FIXTURE DUE TO FIXTURE LOOSENING. PATIENT HAS HAD A HISTORY OF INFECTIONS AND PAIN. INFECTION WILL BE TREATED BY DEBRIDEMENT, LOCAL AND SYSTEMIC ANTIBIOTICS. BATCH DOCUMENTATION REVIEWED. NO DEVIATIONS FOUND IN PRODUCT. PATIENT HAD THE IMPLANT FOR 14 YEARS AND THEREFORE THIS IS NOT CONSIDERED AN EARLY FAILURE. 4T OG (B)(6) 2020 FIXTURE REMOVAL SURGERY PERFORMED. FIXTURE WILL NOT BE REPLACED. NO FURTHER INFORMATION WILL BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141430 OPRA IMPLANT SYSTEM OPRA IMPLANT FIXTURE 18MM PJY INTEGRUM AB IBC0012 20020829 07340152100443

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention