BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SOLERA SPINAL SYSTEM

    MDR report key: 7081953 · Received December 5, 2017

    Report

    Report Number
    1030489-2017-02451
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    November 8, 2017
    Report Date
    January 23, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS A PACK OF FOUR PRODUCTS WITH PART# 6430530, 510K# K143375 AND (B)(4), WHICH IS AVAILABLE FOR MARKET IN THE US. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    X-RAY REVIEW: POST-OP X-RAYS FOR T12-L2 FIXATION ACROSS AN L1 COMPRESSION FRACTURE WERE PROVIDED. ONE OF THE T12 SET SCREWS HAD COME OFF THE TULIP. THE HARDWARE APPEARED UNDERSIZED. HARDWARE FAILED AT THIS TRANSITIONAL SEGMENT BECAUSE OF WHICH BONY FUSION HASN¿T OCCURRED WHICH IS AN EXPECTED LONG TERM OCCURRENCE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 THE PATIENT UNDERWENT TH12-L2 POSTERIOR FUSION (1A1B) DUE TO LUMBAR CANAL STENOSIS. AFTER 6 MONTHS POST SURGERY, THE SET SCREW AT RIGHT SIDE OF TH12 WAS FOUND BACKED OUT. REPORTEDLY, THE PATIENT HAD LOW BACK PAIN. REVISION SURGERY WAS SCHEDULED FOR REMOVAL OF IMPLANTS.

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED IN WHICH THE SET SCREW WAS EXPLANTED. NO PATIENT COMPLICATION WAS REPORTED IN THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864807 CD HORIZON SOLERA SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention