BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 10435419 · Received August 21, 2020

    Report

    Report Number
    1030489-2020-01115
    Event Type
    Malfunction
    Date Received
    August 21, 2020
    Date of Event
    July 31, 2020
    Report Date
    August 20, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    K982990
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 UPN# 00673978042640 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A FIELD CONTACT REGARDING A PATIENT WITH A PRE-OPERATIVE DIAGNOSIS OF CONGENITAL SCOLIOSIS, UNDERGOING A REVISION SURGERY FOR EXTENDING THE GROWING ROD, FOR A SPINAL THERAPY. IT WAS REPORTED THAT, WHEN AN ATTEMPT WAS MADE TO LOOSEN THE DOMINO SET SCREW TO PERFORM EXTENDING OF THE GROWING ROD (DURING A REVISION SURGERY), THE SET SCREW STRIPPED AND DID NOT ROTATE. AFTER A TRIAL-AND-ERROR, THE SET SCREW DIDN'T TURN AFTER ALL, AND THEN IT WAS CUT WITH AN AIRTOME TO REMOVE THE DOMINO AND WAS REPLACED WITH ANOTHER ONE. IT WAS REPORTED TO BE BROKEN. NO FRAGMENT OF THE IMPLANT OR INSTRUMENT IS REMAINING IN THE PATIENT. THERE WAS A DELAY OF LESS THAN 60 MIN IN THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. DATE OF INITIAL SURGERY: (B)(6) 2019 TYPE OF INITIAL SURGERY PROCEDURE: THORACOLUMBAR VERTEBRA POSTERIOR FIXATION MDT PRODUCTS USED IN INITIAL SURGERY: SOLERA4.75 THE PRODUCT WILL BE RETURNED TO THE PATIENT. ADDITIONAL INFO RECEIVED. THE ID OF THE SCREW DRIVER USED TO LOOSEN THE SET SCREW OF THE DEFECTIVE IMPLANT PROVIDED. THE REPORTED INSTRUMENT WAS RETURNED TO THE LOANER AND THE INSPECTION RESULT WAS ACCEPTABLE. NEITHER IMPLANT NOR DRIVER CAN BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904427 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS GX811H300 0500434W

    Patients

    Seq Age Sex Outcome Treatment
    1