BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 4151659 · Received October 8, 2014

    Report

    Report Number
    1030489-2014-03911
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    K052187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: SPECIFIC LOCATION WITHIN CONSTRUCT UNKNOWN. THREADS DO NOT SHOW EVIDENCE OF CROSS THREADING. MICROSCOPICALLY EXAMINED SET SCREW ROD INTERFACE NODE AND SURFACE; SET SCREW NODE HEIGHT AND MORPHOLOGY OF DEFORMATION ARE ATYPICAL OF FULL TIGHTENING. NODE DEFORMATION HEIGHT (@ CENTER) IDENTIFIED TO BE SIGNIFICANTLY HIGHER THAN A BENCH COMPARISON SAMPLE. MICROSCOPICALLY EXAMINED MAS HEAD; ASYMMETRICAL CROWN WITNESS MARKS NOTED ON THE SURFACE MAS, CONSISTENT WITH ANGULATED ROD AT FINAL TIGHTENING. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH INCOMPLETE SEATING OF THE ROD AT FINAL TIGHTENING OF THE SET SCREW.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER FILMS WERE SUPPLIED FOR REVIEW WHICH FOUND: THREE VIEWS ARE PROVIDED AN AP AND LATERAL X-RAY AND A LATERAL REVERSE IMAGE LATERAL OF A LUMBAR SPINE AFTER SURGICAL TREATMENT FOR AN L2 FRACTURE. THESE HAVE APPARENTLY BEEN TAKEN AFTER THE FIRST REVISION AS THESE ARE LEGACY SCREWS AND RODS AND NOT LONGITUDE. THE FRACTURE APPEARS TO BE ABOUT 20% COMPRESSED ANTERIORLY WITH EXAGGERATED KYPHOSIS THROUGH THE LEVEL. PEDICLE SCREWS EXTEND FROM T12, L1, L3 AND L4. MINIMAL ROD CONTOURING IS PRESENT. THE SET SCREWS ON L3 AND L4 HAVE BACKED OUT ALLOWING SOME RECURRENCE OF PATHOLOGIC KYPHOSIS. NO SPECIFIC REASON FOR SET SCREW BACK OUT IS SEEN. PSEUDO ARTHRITIS CAN LEAD TO METAL FAILURE AND SCREW BACK OUT, HOWEVER IMPLANTS ARE DESIGNED TO SUPPORT FUSION FOR LONGER THAN 6 MONTHS IF THE PATIENT'S ACTIVITY LEVELS WERE APPROPRIATELY CONTROLLED. A 4TH IMAGE IS A CORONAL CT RECONSTRUCTION OF THE SAME T12 TO L4 CONSTRUCT. IT VERIFIES THAT THE PEDICLE SCREWS ARE WELL POSITIONED WITHIN THE PEDICLES AND THAT THERE IS A SAGITTAL SPLIT OF THE L2 FRACTURE DOCUMENTING IT AS A TWO COLUMN INJURY OR BURST FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TO IMPLANT NEW HARDWARE AT T12-L4 TO TREAT A L2 FRACTURE. IT WAS REPORTED THAT 6 MONTHS POST-OP THE PATIENT EXPERIENCED PAIN IN THE LOWER BACK AND 7 MONTHS POST-OP THE PATIENT WENT IN TO SEE THE SURGEON. DURING THE VISIT THE PATIENT UNDERWENT A MRI AND CT WHICH SHOWED NON-UNION AND THAT THE LOWER 3 SET SCREWS HAD DISLODGES. THE SET SCREWS MIGRATION ALLOWED THE ROD TO MOVE AND PIERCE INTO THE PATIENT¿S SKIN. THE PATIENT UNDERWENT A REVISION TO REMOVE THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633189 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H13J4858

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR Hospitalization| R SCREWS, RODS, BMP