BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPONSE 5.5/6.0 SPINE SYSTEM

    MDR report key: 6441955 · Received March 29, 2017

    Report

    Report Number
    3006460162-2017-00005
    Event Type
    Injury
    Date Received
    March 29, 2017
    Date of Event
    March 2, 2017
    Report Date
    January 15, 2017
    Manufacturer
    ORTHOPEDIATRICS CORP.
    Product Code
    OSH
    PMA / PMN Number
    K15600
    Removal / Correction Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTIONS: PATIENT AGE, UDI, EXPLANT DATE. ADDITIONAL INFORMATION: CUSTOMER DID NOT RETURN THE EXPLANTED DEVICES TO ORTHOPEDIATRICS, CORP. CORRECTION/REMOVAL NUMBER: 3006460162-04-11-2017-001-C. A DEVICE HISTORY RECORDS REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE SURGEON NOT ADEQUATELY FOLLOWING THE STEPS OUTLINED IN THE SURGICAL TECHNIQUE FOR "FINAL TIGHTENING" OF THE SET SCREW AND THE CONFIRMATION THAT THE ROD IS FULLY SEATED INTO THE BOTTOM OF THE PEDICLE SCREW PRIOR TO TINAL TIGHTENING. UPDATED SURGICAL TECHNIQUE, SALES REP NOTIFICATIONS AND TRAINING HAS BEEN UPDATED AND/OR DISTRIBUTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ORTHOPEDIATRICS WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    SCHEUERMANN'S KYPHOSIS CASE DONE (B)(6) 2016. USED ALL POLY SCREWS AND 6.0 COBALT CHROME RODS. PATIENT CAME BACK FOR 1 YEAR FOLLOW UP, AND BOTTOM 3 SCREWS ON BOTH SIDES BECAME DISENGAGED. AT TIME OF REVISION SURGERY, SALES REP NOTED THAT SURGEON STATED THAT HE HAD USED THE WRONG INSTRUMENT (JIMMY DEVICE) TO ACTUALLY REDUCE ROD INTO PEDICLE SCREWS, SO THEREFORE THEY WERE NOT TIGHTENED AS HE HAD THOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225671 RESPONSE 5.5/6.0 SPINE SYSTEM PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS OSH ORTHOPEDIATRICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention