BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04615

    MDR report key: 3251235 · Received July 29, 2013

    Report

    Report Number
    2520274-2013-04615
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, THE SURGEON PERFORMED AN UNSPECIFIED PROCEDURE AND IMPLANTED THE PATIENT WITH A STERNAL PLATE AND SCREWS. SUBSEQUENTLY, THE PATIENT FELT LIKE THE PLATE WAS NOT SECURE. THE PATIENT RETURNED TO SURGERY ON (B)(6) 2013. IT WAS FOUND THAT A SCREW HAD BACKED OUT AND THE SURGEON ELECTED TO REMOVE PLATE AND UNSPECIFIED NUMBER OF SCREWS. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PLATE AND SCREWS WERE GIVEN TO THE PATIENT. IT IS UNKNOWN WHETHER ANOTHER DEVICE WAS IMPLANTED. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352266 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention