BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEO BONE SCREW SYSTEM

    MDR report key: 17113652 · Received June 12, 2023

    Report

    Report Number
    3012478585-2023-00001
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    May 24, 2023
    Report Date
    June 12, 2023
    Manufacturer
    GRAMERCY EXTREMITY ORTHOPEDICS
    Product Code
    HWC
    UDI-DI
    B47110205040
    PMA / PMN Number
    K161904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BROKEN SCREW DID NOT CONTRIBUTE TO DEATH OR SERIOUS INJURY, AND A SIMILAR OCCURRENCE WITH A SIMILAR DEVICE WOULD NOT LIKELY CONTRIBUTE TO DEATH OR SERIOUS INJURY. THE SCREW WAS IMPLANTED FOR APPROXIMATELY 1 YEAR WITHOUT ANY REPORTED ISSUE. IT IS UNKNOWN IF THE BROKEN SCREW WAS THE PRIMARY DRIVER FOR THE PATIENT'S VISIT TO THE SURGEON WHEN/WHERE THE BROKEN SCREW WAS DISCOVERED IN THIS PATIENT WITH CHARCOT FOOT AND WITH FLAT FOOT DEFORMITY. GEO HAS DETERMINED THIS TO BE A REPORTABLE EVENT SOLELY BASED ON THE FACT A GEO PRODUCT WAS EXPLANTED AS PART OF THIS FOLLOW-UP PROCEDURE.

    Description of Event or Problem · 0

    ON 05/23/2023, SURGEON NOTIFIED GEO DISTRIBUTOR THAT A GEO BONE SCREW WAS BROKEN IN PATIENT'S FOOT, POST-SURGERY. ON (B)(6) 2023, PATIENT UNDERWENT SURGERY TO REMOVE (EXPLANT) THE SCREW. THE SCREW WAS ORIGINALLY IMPLANTED IN THE PATIENT ON (B)(6) 2022. THE SURGEON NOTED THE PATIENT HAD SEVERE CHARCOT FOOT AND FLAT FOOT DEFORMITY. THE SURGEON INDICATED THAT THE JOINT MAY HAVE NOT BEEN PREPPED ENOUGH AND THERE WAS MICRO MOTION IN THE JOINT THAT SCREW WAS CROSSING. ANOTHER SCREW (UNKNOW TYPE, SPECIFICATIONS, ETC.) WAS INSERTED TO REPLACE THE SCREW THAT WAS EXPLANTED, AND A PORTION/FRAGMENT OF THE ORIGINAL SCREW WAS LEFT IN THE BONE. THERE WERE NO COMPLICATIONS OR ADVERSE OUTCOMES REPORTED WITH THE FOLLOW-UP SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010697 GEO BONE SCREW SYSTEM BONE SCREW HWC GRAMERCY EXTREMITY ORTHOPEDICS N/A N/A B47110205040

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other