BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH

    MDR report key: 5537165 · Received March 31, 2016

    Report

    Report Number
    1030489-2016-00852
    Event Type
    Injury
    Date Received
    March 31, 2016
    Report Date
    March 11, 2016
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. PMA 510(K): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 828-083, 510K # K880215 WAS CLEARED IN THE UNITED STATES. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, THE PLACED ROD INTERFERED THE SKIN. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. POST-OP, HOOK AT THE MOST CRANIAL OF TH5 CAME OFF, NESPLON BROKE AND L/R RODS MOVED TOWARD DORSAL. RODS AT TH LEVELS WERE CUT IN REVISION SURGERY. THE SURGEON TOLD THAT MIGRATION OCCURRED DUE TO THE HOOK AND WIRE WERE OVERLOADED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193248 TSRH APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R