BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNALOCK 360 MULTI-IMPLANT SYSTEM

    MDR report key: 8482769 · Received April 4, 2019

    Report

    Report Number
    0001032347-2019-00207
    Event Type
    Injury
    Date Received
    April 4, 2019
    Date of Event
    March 6, 2019
    Report Date
    July 29, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036190668
    PMA / PMN Number
    K163007
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 REPORTS: 0001032347-2019-00208-1 & 0001032347-2019-00209-1.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF EVIDENCE SUGGESTING THE REVISION WAS PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. NO PRODUCT WAS RETURNED AND THE DISTRIBUTOR REPORTED THE PARTS WERE DISCARDED. ACCORDING TO THE PAY-ONE-PRICE FORM SIGNED AND SUBMITTED BY THE SURGEON, THE REVISION WAS DUE TO STERNAL COMPLICATIONS WHICH INDICATES THERE IS NO ALLEGED MALFUNCTION OF THE PRODUCTION AND THIS COULD BE DUE TO PATIENT CONDITION. HOWEVER, THE SURGEON SIGNED 'YES' TO IF THE REVISION IS RELATED IN ANY WAY (EVEN IF NOT THE PRIMARY CAUSE) TO THE STERNALOCK DEVICE UTILIZED IN THE PATIENT'S ORIGINAL PROCEDURE. THERE IS INSUFFICIENT INFORMATION AND MATERIALS PROVIDED TO MAKE THIS DETERMINATION. 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: 0001032347-2019-00209-2 & 0001032347-2019-00208-2.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). 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 REPORTS: 0001032347-2019-00208 & 0001032347-2019-00209.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION DUE TO A STERNAL COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276215 STERNALOCK 360 MULTI-IMPLANT SYSTEM PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A 614720 00841036190668

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R