BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-06635

    MDR report key: 3381781 · Received October 2, 2013

    Report

    Report Number
    2520274-2013-06635
    Event Type
    Injury
    Date Received
    October 2, 2013
    Date of Event
    March 2, 2012
    Report Date
    September 5, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NEW INFORMATION; X-RAY TAKEN DURING INITIAL IMPLANT PROCEDURE. (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE REPORT IS FOR TWO UNKNOWN PEDICLE SCREWS (PART/LOT NUMBERS ARE UNKNOWN). THE INVESTIGATION COULD NOT BE COMPLETED;NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NOT LOT NUMBER WAS AVAILABLE FOR THE PART NUMBER PROVIDED. THE DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    STUDY COORDINATOR PROVIDED OPERATIVE REPORT FROM (B)(6) 2011. UPON REVIEW OF OPERATIVE REPORT, IT INDICATED A HISTORY OF LATERAL AND ANTERIOR POSTERIOR X-RAYS WERE TAKEN TO CONFIRM EXCELLENT POSITION OF THE PLIF BONE GRAFTS.

    Description of Event or Problem · 1

    COMPANY REPRESENTATIVE STATED A REPORT WAS RECEIVED REGARDING A CHRONOS STRIP STUDY PATIENT IMPLANTED ON (B)(6) 2011, WHO RETURNED TO THE STUDY SITE ON (B)(6) 2012 FOR A FOLLOW-UP APPOINTMENT, COMPLAINING OF LUMBAR RADICULOPATHY AT L1-L2, AND WAS TREATED WITH LUMBAR INTER-LAMINAR EPIDURAL STEROID INJECTION. THE PATIENT HAD BEEN PREVIOUSLY EXPERIENCING BUTTOCKS, GROIN AND RIGHT LEG PAIN FOR GREATER THAN A YEAR AND WAS SUBSEQUENTLY IMPLANTED ON (B)(6) 2011 WITH CHRONOS 1 STRIP, 10CC BMA, 7CC LOCAL BONE AT L4-L5. PRIOR TO IMPLANTATION, THE PATIENT WAS TREATED WITH NSAIDS, AND INJECTIONS. UPON EXAMINATION, THE INVESTIGATOR DETERMINED THAT THE ADVERSE EVENT WAS DEFINITELY NOT RELATED TO THE DEVICE, AND WAS DEFINITELY NOT RELATED TO THE SURGERY. THE INVESTIGATOR ALSO REPORTED THE SEVERITY OF THE EVENT TO BE MODERATE: SOME LIMITATION OF USUAL ACTIVITIES. IT WAS NOTED BY THE CASE REPORT FORMS, THAT AN UNKNOWN NUMBER OF PEDICLE SCREWS WERE USED FOR THE PATIENTS L4-L5. THIS REPORT IS FOR TWO UNKNOWN PEDICAL SCREWS (PART/LOT NUMBERS UNKNOWN). THIS IS REPORT 2 OF 2 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497661 HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention