BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7.3MM CANNULATED LOCKING SCREW 75MM

    MDR report key: 3962230 · Received July 28, 2014

    Report

    Report Number
    2520274-2014-12877
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 1, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    PK000066
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. 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

    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

    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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HOSPITAL CALLED TO INQUIRE ABOUT THE SYSTEM USED FOR THIS CASE AS THEY COULD NOT GET THE DETAILS FROM THEIR DATA, BY PROVIDING PATIENT DETAILS, DATA WAS RETRIEVED FROM SAP. PER THE HOSPITAL, THE PATIENT HAS A NONUNION AND AS A RESULT, THE IMPLANT BROKEN. THE PATIENT WILL HAVE A REVISION SURGERY IN INDIA. NO FURTHER DETAILS CAN BE PROVIDED. THIS COMPLAINT INVOLVES (3) DEVICES. THIS REPORT IS 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439566 7.3MM CANNULATED LOCKING SCREW 75MM SCREW,FIXATION,BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention