BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2060277 · Received April 15, 2011

    Report

    Report Number
    1030489-2011-00434
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    January 13, 2009
    Report Date
    March 24, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (REVISION SURGERY). DISCS CONTAINING X-RAYS WERE RETURNED TO MEDTRONIC FOR EVALUATION. IMAGES SHOW A LONG CONSTRUCT FOR SCOLIOSIS AT T4 TO ILIAC. SUBSEQUENT FILMS SHOW REMOVAL OF ILIAC SCREWS AND SACRAL SCREWS. LATER FILMS CONFIRM ROD FRACTURE ON THE LEFT SIDE AT L2-3 WITH SUBSEQUENT REMOVAL OF HARDWARE UP TO T10 ON LEFT SIDE AND T11 ON THE RIGHT. THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION.

    Description of Event or Problem · 1

    PT. MEDICAL RECORDS WERE RECEIVED WHICH STATE THAT THE PATIENT UNDERWENT INITIAL SURGERY TO TREAT THORACIC SCOLIOSIS AND LUMBAR DEGENERATIVE DISC DISEASE. SURGERY WAS PLIF L5-S1 WITH PEEK INTERBODY DEVICE AND BMP, AND PSF T4-S1 WITH PEDICLE SCREWS, RODS, CROSSLINK, CABLES, AND ILIAC FIXATION. ON A FOLLOW-UP VISIT APPROXIMATELY 3 YEARS POST-OP THE PATIENT REPORTED ACUTE ONSET OF SHARP PAIN ON THE LEFT SIDE OF HER BACK. SHE ALSO STATED SHE HAD HEARD A LOUD POP, AND FROM THEN ON SHE HAD DISCOMFORT. X-RAYS SHOWED A FRACTURE OF THE LEFT ROD BETWEEN THE L1 AND L3 PEDICLE SCREWS. PER MEDICAL RECORDS, THE PATIENT HAD HAD AN INCIDENT ON (B)(6) 2009 WHERE SHE HAD FALLEN OFF A FENCE, LANDING BACKWARDS, CAUSING SEVERE PAIN AND INJURING HER BACK. PER THE SURGEON'S NOTES, THIS MAY HAVE BEEN WHEN THE ROD ACTUALLY BROKE. PRIOR TO SURGERY CT SCAN SHOWED THE ROD OUT FROM THE L5 PEDICLE ON THE RIGHT SIDE AND THAT THE SETSCREW HAD BACKED OUT. THE PATIENT UNDERWENT ADDITIONAL SURGERY TO REMOVE THE POSTERIOR FIXATION BELOW THE T10 PEDICLE SCREW ON THE LEFT SIDE AND BELOW THE T11 SCREW ON THE RIGHT SIDE. FUSION WAS SOLID WITH NO EVIDENCE OF PSEUDOARTHROSIS. NO ADDITIONAL HARDWARE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM KWP WARSAW ORTHOPEDIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention