BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIRO GROWTH MODULATION SYSTEM

    MDR report key: 23267574 · Received October 10, 2025

    Report

    Report Number
    3000327445-2024-00010
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    November 22, 2024
    Report Date
    October 10, 2025
    Manufacturer
    ORTHOPEDIATRICS CANADA ULC
    Product Code
    OBT
    PMA / PMN Number
    K220190
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SURGEON REPORTED A BROKEN BEAD IN A GIRO IMPLANT TO ORTHOPEDIATRICS CANADA ON (B)(6) 2024, FOLLOWING A FOLLOW-UP SURGERY CONDUCTED 13 MONTHS POST-IMPLANTATION. THE IMPLANT WAS ORIGINALLY USED TO TREAT LIMB LENGTH DISCREPANCY THROUGH GIRO TEMPORARY PHYSIODESIS IN THE DISTAL LEFT FEMUR. THE SURGEON PROVIDED X-RAYS FROM THE INITIAL IMPLANTATION SURGERY AND THE FOLLOW-UP PROCEDURE. INITIAL X-RAYS REVEAL THAT THE MEDIAL COUPLING OF THE GIRO IMPLANT WAS ROTATED APPROXIMATELY 30 DEGREES FROM THE IDEAL AXIAL ALIGNMENT AT THE TIME OF IMPLANTATION. DURING THE FOLLOW-UP SURGERY, X-RAYS SHOWED THAT THE POSTERIOR BEAD OF THE MEDIAL CABLE HAD DISSOCIATED FROM THE CABLE, AND BOTH THE SUPERIOR AND INFERIOR POSTS OF THE IMPLANT, LOCATED ABOVE AND BELOW THE GROWTH PLATE, EXHIBITED BENDING. AN INTERNAL INVESTIGATION BY ORTHOPEDIATRICS CANADA CONCLUDED THAT THE IMPLANT FAILURE WAS CAUSED BY THE INITIAL MISPOSITIONING OF THE MEDIAL COUPLING, WHICH WAS ROTATED BY APPROXIMATELY 30 DEGREES. THIS MISALIGNMENT CREATED EXCESSIVE TENSION ON THE POSTERIOR BEAD OF THE MEDIAL CABLE. OVER TIME, AS THE PATIENT GREW, THE COMBINED TENSION DUE TO GROWTH AND THE INITIAL ROTATION LED TO THE BEAD'S BREAKAGE. FOLLOW-UP X-RAYS ALSO REVEALED THAT THE GIRO FEMALE SLIDING POSTS WERE DEFORMED, APPEARING CURVED, FURTHER SUPPORTING THE CONCLUSION THAT THE IMPLANT ASSEMBLY WAS SUBJECTED TO SIGNIFICANT MECHANICAL FORCES. THIS COMPLICATION REQUIRED RE-OPERATION TO REMOVE AND REPLACE THE BROKEN IMPLANT. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED AS MFR #3000327-2024-00010 ON (B)(6) 2024 BUT WAS REJECTED BY CDRH DUE TO AN INCORRECT FEI NUMBER IN THE ESUBMITTER FORM. IT IS NOW RESUBMITTED WITH THE CORRECT FEI (B)(4)). CAPA INITIATED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    THE BEAD OF THE GIRO IMPLANT BROKE OFF IN PATIENT 13 MONTHS AFTER THE INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311156 GIRO GROWTH MODULATION SYSTEM 4.5 GIRO 20MM OBT ORTHOPEDIATRICS CANADA ULC

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Female Other