BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) STERNAL CABLE SYSTEM

    MDR report key: 6397354 · Received March 10, 2017

    Report

    Report Number
    1833824-2017-00006
    Event Type
    Injury
    Date Received
    March 10, 2017
    Report Date
    March 10, 2017
    Manufacturer
    PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL)
    Product Code
    JDQ
    UDI-DI
    00846468040895
    PMA / PMN Number
    K935481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PIONEER SURGICAL TECHNOLOGY HAS TRIED UNSUCCESSFULLY TO GET MORE INFORMATION FROM THE (B)(6) HOSPITAL THAT THIS TOOK PLACE IN. THIS INCIDENT IS ONE OF THREE PATIENT INCIDENTS THAT WERE REPORTED AT THE SAME TIME FOR THE SAME DEVICE PART AND LOT NUMBER COMBINATION. NONE OF THESE INCIDENTS HAVE BEEN ABLE TO BE CONFIRMED AT THIS TIME. WE WILL CONTINUE TO REQUEST MORE INFORMATION. THE DHR WAS REVIEWED ALONG WITH STERILIZATION RECORDS AND ALL CONFORM TO SPECIFICATIONS. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE COUNTRY OF (B)(6) THAT A PATIENT HAD EXPERIENCED INFECTION AFTER A SURGERY USING PIONEER SURGICAL TECHNOLOGY STERNAL CABLE SYSTEM. NO MORE INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177321 PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) STERNAL CABLE SYSTEM STERNAL CABLE SYSTEM JDQ PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) 400-689 203638 00846468040895

    Patients

    Seq Age Sex Outcome Treatment
    1