BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 7333896 · Received March 13, 2018

    Report

    Report Number
    1030489-2018-00376
    Event Type
    Injury
    Date Received
    March 13, 2018
    Report Date
    July 2, 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

    PART# G7755124 IS NOT MARKETED IN US BUT A SIMILAR DEVICE WITH PART# 7755124, 510(K): K082728 AND UDI: (B)(4) IS MARKETED IN 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

    PRODUCT ANALYSIS: VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED ROD REVEALED THAT THE POST THAT CONNECTS THE TWO HALVES OF THE ROD HAS FRACTURED. THE LOCKING SCREW HAS BEEN DEFORMED ON THE TIP WHERE IT APPEARS IT WAS OVER TORQUED. THE DEFORMATION ON THE TIP OF LOCKING SCREW HAS LEFT A WITNESS MARK AT THE LEVEL OF THE FRACTURE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT OC2 FIXATION FOR ATLANTOAXIAL SUBLUXATION. POST-OP, THE ROD BROKE AND WAS LATER REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177947 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention