BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET SCREW

    MDR report key: 4140247 · Received October 3, 2014

    Report

    Report Number
    1526439-2014-11954
    Event Type
    Injury
    Date Received
    October 3, 2014
    Report Date
    September 11, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NOT RETURNED.

    Description of Event or Problem · 1

    PER PLAINTIFF, FOLLOWING A DIAGNOSIS OF LUMBAR SPINAL STENOSIS IN APPROXIMATELY 2007 AND SEVERAL YEARS OF FAILED CONSERVATIVE MEASURES, PLAINTIFF HAD LUMBAR SPINAL FUSION SURGERY IN 2012. ON OR ABOUT (B)(6) 2012, MINIMALLY INVASIVE PEDICLE SCREW FIXATION WITH POSTEROLATERAL FUSION LUMBAR 4-5, LUMBAR 5-SACRAL 1 WAS PERFORMED. OP NOTES INDICATED THAT THE LEFT L5 SETSCREW DID BREAK OUT OF THE SCREW AND COULD NOT BE REATTACHED. AS SCREWS WERE BEING PLACED CRANIALLY AND CAUDALLY TO THIS, THIS WAS NOT FELT TO BE OF ANY SIGNIFICANT CONCERN." ON OR ABOUT (B)(6) 2012 THE PATIENT HAD COMPLAINTS OF LOWER BACK PAIN, RADIATING NUMBNESS, AND WEAKNESS IN HIS RIGHT LEG. X-RAY REVEALED "THE LOCKING SCREWS IN THE RIGHT L5 AND SI TRANSPEDICULAR SCREWS HAD BACKED OUT AND ARE NO LONGER HOLDING THE VERTICAL BAR IN PLACE. ON OR ABOUT (B)(6) 2012, THERE WAS A SECOND SURGERY WHERE THE LOOSENED RIGHT SIDED L5 AND SI SETSCREWS WERE REPLACED. (B)(6) 2012, RETURNED TO EMERGENCY DEPARTMENT WITH LEFT SIDE LOWER BACK PAIN RADIATING INTO HIS LEFT LEG. DISCHARGED HOME WITH PAIN MEDICATIONS AND INSTRUCTIONS TO CONSULT WITH SURGEON. THIRD SURGERY TOOK PLACE ON (B)(6) 2012 WHERE SURGEON REMOVED AND REPLACED THE SPINAL FUSION HARDWARE. OP NOTES NOTED THAT ¿THE CAP SCREWS ON L5 AND S1 WERE CLEARLY LOOSE AS WELL AS THE CAP SCREWS OF L4." PLAINTIFF STATES THAT, SINCE HIS SURGERIES, HE HAS SUFFERED FROM SHARP, EXCRUCIATING, AND CONTINUOUS PAIN IN HIS BACK WITH RADIATION OF PAIN AND WEAKNESS INTO HIS LEFT LEG. HE HAS UNDERGONE PHYSICAL THERAPY AND PAIN MANAGEMENT AND CONTINUED TO CONSULT WITH SURGEON. PLAINTIFF REPORTS THE SURGEON FIRST NOTED IN CHART THAT THE OPERATION OF (B)(6) 2012 WAS DUE TO DEFECTIVE HARDWARE. BASED ON INFORMATION PROVIDED, EIGHT MFG. MEDWATCH REPORTS ARE BEING SUBMITTED FOR THE DEVICES INVOLVED IN THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620678 SET SCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention