BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 6568455 · Received May 16, 2017

    Report

    Report Number
    1030489-2017-01237
    Event Type
    Malfunction
    Date Received
    May 16, 2017
    Date of Event
    April 20, 2017
    Report Date
    April 21, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 811-300, 510K # K982990 AND (B)(4) WAS CLEARED IN THE UNITED STATES. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INITIAL SURGERY DATE: (B)(6) 2014. INITIAL SURGERY PROCEDURE: PEDICLE SCREW WAS INSERTED IN TH1/2-L1/2/3 REASON FOR REVISION: EXTENDING FOR FIXATION RANGE. PRE-OP DIAGNOSIS FOR THIS PROCEDURE: SCOLIOSIS IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PEDICLE SCREW WAS INSERTED AT TH1/2/3-L1/2/3. POST-OP, BONE UNION WAS NOT ACHIEVED BECAUSE OF GROWING ROD FIXATION FOR SCOLIOSIS. ON (B)(6) 2017, DURING REVISION FOR EXTENDING THE FIXATION RANGE, THE MEDIAL SCREW OF THE LOWER LEFT DOMINO WAS STRIPPED. NO PATIENT COMPLICATIONS WERE REPORTED. NO FRAGMENTS REMAINED INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350360 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR