BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT CHROME ROD

    MDR report key: 4130018 · Received September 30, 2014

    Report

    Report Number
    1526439-2014-11941
    Event Type
    Injury
    Date Received
    September 30, 2014
    Report Date
    September 3, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    CORRECT SET SCREW QUANTITY TO (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, BASED ON DAMAGE OBSERVED TO RETURNED SET SCREWS, IT IS LIKELY THAT THE SET SCREWS WEREN¿T FULLY TIGHTENED TO THE ROD. THIS ALLOWED MOVEMENT BETWEEN THE SETSCREW/ROD INTERFACE RESULTING IN ROD IMPINGEMENT ON THE SET SCREW. AS SUCH, THIS NON CONSTRAINED CONSTRUCT MOVEMENT LIKELY RESULTED IN CONSTRUCT DEVICE LOOSENING, PULLOUT, DISENGAGEMENT, SCREW FATIGUE AND FAILURE. AS NO SYSTEMIC TRENDS HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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

    PATIENT WAS DIAGNOSED WITH TRANSVERSE MYELITIS / NEUROMUSCULAR. ORIGINAL SURGERY WAS (B)(6) 2012 FROM T3 TO PELVIS. POST-OPERATIVE X-RAY EVIDENCE ON (B)(6) 2013 SHOWED BILATERAL ROD DISENGAGEMENT FROM THE ILIAC SCREW. REVISION/REMOVAL OF L3 TO PELVIS WAS (B)(6) 2014: LEFT L3 POLY HEAD AND HEAD OF SCREW CAME OFF- SHANK WAS LEFT IMPLANTED. LEFT L4 POLY HEAD AND HEAD OF SCREW CAME OFF- SHANK WAS LEFT IMPLANTED. RIGHT ILIAC POLY SCREW HEAD WAS OFF. THE SHANK OF THE SCREW WAS LEFT IMPLANTED AND THE POLY AXIAL HEAD WAS NOT RETRIEVED. LEFT L5 SCREW PULLED OUT AND WAS OFF THE ROD BUT THE LOCKING CAP WAS STILL ON THE POLY HEAD. THIS WAS THOUGHT TO HAVE BEEN THE CAUSE OF THE HOLE IN THE PATIENT'S SKIN THAT RESULTED IN AN INFECTION. THIS SCREW WAS RETRIEVED FROM THE PATIENT. ALSO, THE LATERAL CONNECTOR ON THE LEFT WAS DISENGAGED FROM THE ILIAC WING SCREW AND ROD. THIS WAS RETRIEVED. THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED: 1526439-2014-11936 ¿ POLYAXIAL SCREW POST OP BREAKAGE. 1526439-2014-11937 ¿ POLYAXIAL SCREW POST OP BREAKAGE. 1526439-2014-11938 ¿ POLYAXIAL SCREW POST OP BREAKAGE ¿ FRAGMENT LEFT IN PATIENT. 1526439-2014-11939 ¿ POLYAXIAL SCREW PULLOUT, EROSION, PROTRUSION, AND INFECTION. 1526439-2014-11940 - LATERAL CONNECTOR DISENGAGEMENT. 1526439-2014-11941 ¿ ROD DISENGAGEMENT. 1526439-2014-11942 ¿ ROD DISENGAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609353 COBALT CHROME ROD ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention SET SCREWS, 179702000 X 7| TORQUE DRIVER