BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3010441 · Received March 19, 2013

    Report

    Report Number
    1030489-2013-00773
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 18, 2013
    Report Date
    April 2, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. AP <(>&<)> LATERAL X-RAYS OF L4/5 INTERBODY FUSION. THE CAGE IS IN GOOD POSITION. THE SETSCREW ON THE RIGHT SIDE OF THE PICTURE HAS BACKED OUT FROM UPPER RIGHT SCREW.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. MICROSCOPICALLY EXAMINED SET SCREW ROD INTERFACE NODE AND SURFACE. THREADS DO NOT SHOW EVIDENCE OF CROSS THREADING. SET SCREW ROD INTERFACE NODE HEIGHT AND MORPHOLOGY OF NODE DEFORMATION ARE ATYPICAL OF FULL TIGHTENING. NODE DEFORMATION HEIGHT, AT CENTER, IS SIGNIFICANTLY DIFFERENT THAN TYPICAL FROM BENCH TESTED SAMPLE. ROD WITNESS MARKS ON SET SCREW ROD INTERFACE SURFACE SUGGESTS THE ROD MAY HAVE BEEN LOCATED IN THE HEAD AT AN ANGLE OR MISLOCATED IN THE CONSTRUCT. THIS IS INDICATED BY THE ROD WITNESS MARKS ON THE SURFACE OF THE SET SCREW, AND THE ASYMMETRICAL FINAL TIGHTENING WITNESS MARKS. SET SCREW ROD INTERFACE NODE HEIGHT AND WITNESS MARKS INDICATE ROD MAY NOT HAVE BEEN COMPLETELY SEATED IN BONE SCREW AT FINAL TIGHTENING, OR MISLOCATED IN THE CONSTRUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT THE RIGHT L4 SETSCREW IS DISPLACED. HOWEVER, THE PATIENT DID NOT HAVE ANY PAIN. APPROXIMATELY 30 DAYS POST OP, A REVISION SURGERY WAS PERFORMED AND THE SETSCREW WAS REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114075 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H12K1011

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Other