BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2113955 · Received June 3, 2011

    Report

    Report Number
    1030489-2011-00682
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    August 3, 2010
    Report Date
    June 23, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    K090390
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL SETSCREWS ARE STUCK ON THE DOMINOS. ALL SETSCREWS PRESENT WORN BOTTOM SURFACE WHICH HAS BEEN FLATTEN DURING THE TIGHTENING OF THE SETSCREW ON THE ROD. ONE SETSCREW (ON THE CLOSED 5.5 SIDE OF THE DOMINO) PRESENTS THREADS ON THE LATERAL WALL OF THE INTERNAL HEXAGONAL SLOTS WHICH ARE CONSISTENT WITH THE USE OF A SETSCREW EXTRACTOR. THE SECOND SETSCREW (ON THE OPEN 6.35 SIDE OF THE DOMINO) PRESENT MARKS ON THE LATERAL WALL OF THE INTERNAL HEXAGONAL SLOTS COMING FROM THE HEXAGONAL TIP OF THE SCREWDRIVER USED FOR THE REMOVAL. IN ADDITION, THIS SETSCREW PRESENTS A CRACK ALONG ONE CORNER OF THE INTERNAL HEXAGONAL SLOT (THE SMALLEST WALL THICKNESS) WHICH MAY HAPPEN DURING OVER-TIGHTENING AFTER THE BREAKAGE OF THE SETSCREW DURING THE INITIAL SURGERY OR DURING THE REMOVAL OF THE SETSCREW AT THE REVISION SURGERY. THE OPEN 6.35 SIDE OF THE DOMINO CONNECTED TO THE ROD PRESENTS BENT LOWER AND UPPER LIPS WHICH IS CONSISTENT WITH THE ROD CANAL OPENING DUE TO OVER-TORQUE APPLIED ON THE SETSCREW. NO PRE-EXISTING DEFECTS HAVE BEEN IDENTIFIED ON THE IMPLANTS THAT COULD BE RESPONSIBLE OF THE EVENT. THE SETSCREWS WITH REFERENCE (B)(4) ARE NOT THE PROPER SETSCREWS TO BE USED WITH THE DOMINOS. THE PROPER SETSCREW INCLUDED IN THE SET CONFIGURATION IS (B)(4). THE FLATTEN SURFACE OF THE SETSCREW (B)(4) AND THE ROD CANAL LIP BENDING OF ONE DOMINO MAY BE EXPLAINED BY A HIGHER BREAK-OFF TORQUE THAN THE ONE OF THE SETSCREW (B)(4). THE HIGHER BREAK-OFF TORQUE OF THE SETSCREW (B)(4) COMBINED WITH THE REDUCED CLEARANCE BETWEEN THE THREAD OF THE SETSCREW (B)(4) AND THE THREAD OF THE DOMINO AND CONNECTOR (COMPARED TO THE LARGEST CLEARANCE BETWEEN THE THREAD OF THE SETSCREW (B)(4) AND THE THREAD OF THE DOMINO AND CONNECTOR) MAY ALSO EXPLAIN WHY THE SETSCREWS MAY BE STUCK IN SOME CIRCUMSTANCES. OTHER FRACTURES SUCH AS BLOOD OR TISSUE AROUND THE THREADS MAY ALSO LEAD TO STUCK SETSCREW.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL FUSION PROCEDURE WITH POSTERIOR FIXATION DUE TO TRAUMA. A REVISION SURGERY WAS DONE NINE MONTHS POST-OP TO REMOVE THE HARDWARE AT THE PATIENT'S REQUEST. DURING THE REVISION, THE SURGEON COULD NOT REMOVE THE SETSCREW FROM THE CONNECTOR. THE SURGEON HAD TO CUT THE CONSTRUCT OUT OF THE PATIENT, EXTENDING THE SURGICAL TIME SIX HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. 0019149W

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention