BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA® SPINAL SYSTEM

    MDR report key: 7989147 · Received October 22, 2018

    Report

    Report Number
    1030489-2018-01386
    Event Type
    Malfunction
    Date Received
    October 22, 2018
    Date of Event
    July 12, 2018
    Report Date
    December 25, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS SOLD AS A PACK OF 4 PRODUCTS WHICH BEAR THE SAME PART NUMBER AND IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER THE CONSTITUENT PRODUCTS WITH CATALOG # 6430530, 510K #K143375 AND UDI #(B)(4) WAS CLEARED IN THE UNITED STATES. 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

    PRODUCT ANALYSIS: MACROSCOPIC AND VISUAL EXAMINATION REVEALED THREAD CREST/FLANK DAMAGE; 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 BONE SCREW HEAD FOUND THE SET SCREW WAS UNABLE TO BE FULLY ENGAGED. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISALIGNMENT OF THE BONE SCREW HEAD AND SET SCREW THREADS DURING CONSTRUCT ASSEMBLY. 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 WAS PRE-OPERATIVELY DIAGNOSED WITH STENOSIS AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) SURGERY AT L4-5 LEVELS. DURING SURGERY, THE SET SCREW AT L5 IDLED AT THE FINAL TIGHTENING. THE PRODUCT CAME IN CONTACT WITH PATIENT. THERE WAS A DELAY OF LESS THAN 60 MINUTES AS A RESULT OF THIS EVENT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831444 CD HORIZON® SOLERA® SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0648964W

    Patients

    Seq Age Sex Outcome Treatment
    1