BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6462896 · Received April 6, 2017

    Report

    Report Number
    1030489-2017-00762
    Event Type
    Malfunction
    Date Received
    April 6, 2017
    Date of Event
    March 10, 2017
    Report Date
    March 10, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG# 8115545, 510K# K030840 AND (B)(4) IS APPROVED FOR SALE IN US. THE DEVICE IS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WITH DEGENERATIVE LUMBAR SCOLIOSIS UNDERWENT POSTERIOR SPINAL FUSION AFTER OBLIQUE LUMBAR INTER-BODY FUSION AT LEVELS TH10-SAI. INTRA-OP, THE CROSSLINK COULD NOT CONNECT PROPERLY WITH THE ROD. THE CROSSLINK WAS PLACED IN THE PATIENT¿S BODY BUT AFTER FINAL TIGHTENING, IT COULD NOT BE CONNECTED CORRECTLY WITH ROD AND CAME OFF. IT WAS DECIDED TO REPLACE IT BUT ONE SIDE SCREW OF THE CROSSLINK WAS STRIPPED AND IT WAS IMPOSSIBLE TO BE REMOVED. THE SURGEON DECIDED THAT THE CROSSLINK SHOULD BE REMOVED PARTIALLY AND LEFT IT IN THE PATIENT¿S BODY. THERE WAS A DELAY OF MORE THAN 60 MINUTES AS A RESULT OF THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245329 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0476798W

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR