BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 7840933 · Received September 3, 2018

    Report

    Report Number
    1030489-2018-01197
    Event Type
    Malfunction
    Date Received
    September 3, 2018
    Date of Event
    August 7, 2018
    Report Date
    January 14, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. THIS PART IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG#6543535 AND 510K#K063083, UDI#(B)(4) IS APPROVED FOR SALE IN US. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: MACROSCOPIC AND OPTICAL EXAMINATION REVEALED THREAD CREST/FLANK DAMAGE IN THE HEAD OF THE SCREW. THIS DAMAGE APPEARS TO HAVE INITIATED NEAR THE START OF THE THREAD, AND IS EVIDENT AROUND THE DAMAGED PORTION OF THE THREAD. FUNCTIONAL EVALUATION WITH A SAMPLE SET SCREW CONFIRMED THE ROD WOULD ENGAGE THE SET SCREW BUT THE FIT WAS LOOSE. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH THE MISALIGNMENT OF THE SET SCREW WHEN TIGHTENED. THE FIRST THREAD ON THE BOTTOM OF THE SCREW APPEARS TO HAVE BEEN DAMAGED DURING THE REMOVAL PHASE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS: IDIOPATHIC SCOLIOSIS PROCEDURE: ANTERIOR FIXATION LEVELS IMPLANTED: TH12-L3 IT WAS REPORTED THAT INTRA-OP, WHEN PERFORMING FINAL TIGHTENING, THE SET SCREW OF THE SCREW WHICH WAS AT THE POSTERIOR SIDE OF L2 WAS THREADED AND IDLED. IT WAS CONSIDERED THE SET SCREW IDLED DUE TO THE SCREW HEAD BEING OPEN. THERE WAS A DELAY IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. THE SCREW BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681878 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0534310W

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR