BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PECTUS SYSTEM ELONGAGED STABILIZER 60 X017 MM

    MDR report key: 8314894 · Received February 7, 2019

    Report

    Report Number
    0001032347-2019-00091
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Date of Event
    December 10, 2018
    Report Date
    May 21, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K061384
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE PRODUCTS WERE NOT RETURNED AND NO PHOTOS WERE PROVIDED. NO ADDITIONAL INFORMATION WAS RECEIVED. FOR THESE REASONS, NO FUNCTIONAL TESTING OR VISUAL EVALUATION COULD BE CONDUCTED. THE COMPLAINT IS NON-VERIFIABLE. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00087-1.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET MICROFIXATION PECTUS SYSTEM DURAN 14.5" TI PECTUS BAR, CATALOG #: PT-2778, LOT #: 873690. UNKNOWN WIRE, CATALOG #: NI, LOT # NI. THERAPY DATE: (B)(6) 2018. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORT: 0001032347-2019-00087.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BARS WERE BENT IN THE WRONG WAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108397 PECTUS SYSTEM ELONGAGED STABILIZER 60 X017 MM PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1