BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH

    MDR report key: 7628635 · Received June 22, 2018

    Report

    Report Number
    1030489-2018-00893
    Event Type
    Injury
    Date Received
    June 22, 2018
    Report Date
    September 26, 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 NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 828-090, 510K# K964275 AND UDI (B)(4) IS APPROVED FOR SALE IN US. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL REVIEW CONFIRMS ROD BROKEN. MULTIPLE WITNESS MARKS NOTED ON ROD. NO SURFACE DEFECT IDENTIFIED IMMEDIATELY ADJACENT TO THE AREA OF INITIAL CRACK PROPAGATION THAT COULD CONTRIBUTE TO CRACK INITIATION AND PROPAGATION. SEVERE FRACTURE SURFACE DAMAGE AND SMEARING IS NOTED. MICROSCOPIC EXAMINATION IS PRECLUDED DUE TO THE EXTENT OF THE FRACTURE SURFACE DAMAGE. THE DIAMETER OF THE ROD WAS CHECKED IN IS WITH IN PRINT SPEC ON ALL THREE SECTION RETURNED. DUE TO IMDRF HARMONIZATION, SOME PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. 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 FIXATION AT T3-ILIAC DUE TO DEGENERATION AND VERTEBRAL BODY REPLACEMENT WAS PERFORMED AT L3 AND T12. POST-OP, THE ROD NEAR L4/5,L5/S WAS BROKEN AND A REVISION SURGERY WAS PERFORMED TO REPLACE THE ROD. NO FRAGMENTS OF THE BROKEN PART REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472565 TSRH APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R