BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM CORTEX SCREW SELF-TAPPING 30MM

    MDR report key: 4587686 · Received March 10, 2015

    Report

    Report Number
    2520274-2015-11674
    Event Type
    Injury
    Date Received
    March 10, 2015
    Report Date
    February 25, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: JDS. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 A PATIENT MAY HAVE A OSTEOMYELITIS AROUND A "SHIN" IMPLANT. X-RAYS HAVE BEEN PERFORMED WHICH HAVE BE INDETERMINANT AND THE PHYSICIAN WOULD LIKE TO DO A MAGNETIC RESONANCE IMAGING (MRI) BUT WANTS TO DETERMINE THE IMPLANT COMPOSITION BEFORE SCANNING. THIS REPORT IS 8 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163725 3.5MM CORTEX SCREW SELF-TAPPING 30MM SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention