BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI CANCELLOUS POLYAXIAL SCREW 18MM

    MDR report key: 4196760 · Received October 23, 2014

    Report

    Report Number
    2520274-2014-14301
    Event Type
    Injury
    Date Received
    October 23, 2014
    Report Date
    September 26, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWP
    PMA / PMN Number
    PK142460
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT ID: (B)(6). ADDITIONAL PRODUCT CODES-MNJ, MNI. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 THE PATIENT WAS IMPLANTED WITH SYNAPSE CONSTRUCT ON (B)(6) 2010. IT WAS REPORTED PATIENT IS COMPLAINING OF PAINFUL HARDWARE. PATIENT IS SCHEDULED FOR A REVISION SURGERY TO REMOVE THE HARDWARE ON (B)(6) 2014. PATIENT RETURNED TO SURGEON TO REMOVE PAINFUL HARDWARE ON (B)(6) 2014. THE SURGERY WAS COMPLETED WITHOUT ANY REPORTED COMPLICATIONS. THERE WERE NO REPORTS OF BROKEN HARDWARE, HOWEVER ALL 29 PARTS WILL BE LISTED DUE TO PATIENT PAIN AT AN UNSPECIFIED LOCATION. NO PRODUCT WILL BE RETURNED; IT REMAINS IN THE CUSTODY OF THE HOSPITAL. THIS IS REPORT NUMBER 27 OF 29 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676043 4.0MM TI CANCELLOUS POLYAXIAL SCREW 18MM APPLIANCE,FIXATION,SPINAL INTERLAMINAL KWP SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention