BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2080470 · Received May 6, 2011

    Report

    Report Number
    1030489-2011-00521
    Event Type
    Injury
    Date Received
    May 6, 2011
    Report Date
    January 15, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT BILATERAL LAMINECTOMY AND FACETECTOMIES AT L4-5 AND L5-S1 TO TREAT SPONDYLOLISTHESIS GRADE 1 OR 2 WITH HIGH GRADE STENOSIS. OPERATIVE NOTES STATE THAT THE L4-L5 AND L5-S1 FACET JOINTS WERE SEVERELY OVERGROWN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 4 DAYS LATER. X-RAYS TAKEN 17 DAYS POST-OP LOOKED GOOD; 41 DAYS POST-OP, X-RAYS WERE TAKEN AND LOOKED GOOD, AND THE PATIENT WAS GIVEN AN LSO BRACE; 102 DAYS POST-OP, X-RAYS REVEALED THAT THE S1 SCREWS WERE BROKEN BILATERALLY. THERE WAS MORE SUBLUXATION THAN PREVIOUSLY NOTED. THE SURGEON ORDERED A CT SCAN AND INSTRUCTED THE PATIENT TO CONTINUE TO WEAR THE BRACE. NOTES FROM THIS VISIT REVEAL PATIENT BEGAN NEW BIPOLAR DEPRESSION MEDICATION. AT 116 DAYS POST-OP, ADDITIONAL IMAGING SHOWED GROSS INSTABILITY AT L5S1 WITH SUBLUXATION AND FRACTURED S1 SCREWS. EXPLORATION AND REPAIR WERE DETERMINED TO BE NEEDED. THE SURGEON ALSO NOTED THAT LARGER SCREWS WERE NEEDED. AT 138 DAYS POST-OP, THE PATIENT UNDERWENT A REVISION SURGERY. DOCTOR'S NOTES STATE THAT S1 SCREW BROKEN, L4 SCREWS WERE TIGHT; L5 SCREWS WERE LOOSE AND WERE REMOVED AND REPLACED WITH LARGER SCREWS. FRAGMENTED SCREWS WERE PARTIALLY WITHDRAWN AND ALSO REPLACED WITH LARGER SCREWS. THE PATIENT WAS DISCHARGED FROM HOSPITAL 4 DAYS LATER. AT 50 DAYS AFTER THE REVISION SURGERY, NOTES FROM AN OFFICE VISIT STATE THERE WAS A STABLE FUSION WITH GOOD PAIN RELIEF. THE PATIENT HAD CONSISTENT FOLLOW-UP VISITS POSTOP WITH NO NOTED ISSUES AND CONTINUES TO DO WELL PER PROGRESS FOLLOW-UP NOTES BY DOCTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE WITH RODS AND SCREWS. THE PATIENT REPORTED THAT A REVISION SURGERY WAS REQUIRED 4 MONTHS POST-OP TO REPLACE TWO BROKEN SCREWS AT THE BOTTOM OF THE CONSTRUCT. THE PATIENT REPORTED EXPERIENCING DEPRESSION FOLLOWING THE REVISION SURGERY. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI KWP MEDTRONIC SOFAMOR DANEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RODS