BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4242361 · Received November 11, 2014

    Report

    Report Number
    2520274-2014-14578
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE UNKNOWN SCREW/UNKNOWN LOT NUMBER. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A C3-C6 SURGICAL PROCEDURE ON (B)(6) 2014, A PATIENT¿S SPINAL CORD WAS HIT. THE PROCEDURE INVOLVED SYNAPSE INSTRUMENTATION. THE SURGEON WAS IN THE PROCESS OF THE FINAL TIGHTENING OF A SYNTHES SET SCREW WITH A SYNTHES SCREWDRIVER WHEN THE MAYFIELD CAME LOOSE. THE MAYFIELD IS AN UNKNOWN NON-DEPUY SYNTHES DEVICE. THE LOOSENING OF THE MAYFIELD RESULTED IN THE PATIENT¿S HEAD FALLING, AND THE SURGEON SLIPPING OFF THE SET SCREW AND HITTING THE SPINAL CORD. NO REPORTED HARM TO THE PATIENT WAS NOTED. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726851 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention