BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METATARSAL HEAD LONG OR METATARSAL HEAL XLONG

    MDR report key: 3001315 · Received March 5, 2013

    Report

    Report Number
    2027754-2013-00002
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    October 1, 2012
    Report Date
    February 26, 2013
    Manufacturer
    OSTEOMED
    Product Code
    LZJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY OUR TERRITORY MANAGER THAT AFTER VIEWING THE X-RAYS, THE DOCTOR OBSERVED THAT THE LEFT REFLEXION IMPLANT WAS DISLOCATED AND THERE WAS A FRACTURE IN THE CORTEX OF THE PROXIMAL PHALANX. THEREFORE, ON (B)(6) 2013, THE DOCTOR REMOVED THE REFLEXION IMPLANT FROM THE PATIENT'S LEFT GREAT TOE AND NOTICED THE IMPLANT WAS COMPLETELY DISLOCATED, WITH NO CONTACT BETWEEN THE TWO IMPLANTS. THE PROXIMAL IMPLANT CAME OUT FAIRLY EASILY, AND DID NOT APPEAR TO HAVE BEEN PLACED USING A CEMENT PRODUCT. THE DISTAL IMPLANT WAS MORE DIFFICULT TO REMOVE. IT WAS SITTING VERY PLANTAR, AND ALSO DID NOT APPEAR TO HAVE BEEN CEMENTED INTO PLACE. ACCORDING TO THE IFU FOR THE REFLEXION TOE SYSTEM, THE DEVICE IS INTENDED FOR CEMENTED USE ONLY. THE X-RAYS WERE NOT AVAILABLE TO US FOR REVIEW AND THE IMPLANTS WERE NOT SENT BACK TO US FOR EVALUATION. NOT HAVING THIS INFORMATION PREVENTS US FROM DETERMINING THE ROOT CAUSE FOR THE COMPLAINT. AS A NOTE, IT IS STATED IN THE IFU THAT THE DEVICE IS INTENDED FOR CEMENT FIXATION ONLY. BASED ON THE INFORMATION PROVIDED THERE IS A POSSIBILITY THAT THE SURGEON WHO IMPLANTED THE PARTS IN 2010 MAY NOT HAVE FOLLOWED THE IFU FOR USING BONE CEMENT AND THE IMPLANT WAS NOT CEMENTED IN PLACE. THE NAME OF THE ORIGINAL DOCTOR COULD NOT BE OBTAINED FOR FOLLOW UP. THERE WERE NO OTHER SIMILAR COMPLAINTS FOR THESE IMPLANTS. FOLLOWING REMOVAL, THE SURGEON PERFORMED A BONE GRAFT AND FUSED THE GREAT TOE USING PLATES AND SCREWS. IT WAS REPORTED THAT THE SURGERY WENT WELL.

    Description of Event or Problem · 1

    THE REFLEXION IMPLANT WAS IMPLANTED IN THE LEFT BIG TOE IN 2010 BY A DOCTOR AT THE (B)(6), IN (B)(6) 2012, THE PATIENT CAME BACK IN THE VA OUTPATIENT CLINIC AND SAW ANOTHER DOCTOR WHO WAS NOT THE DOCTOR WHO ORIGINALLY IMPLANTED THE REFLEXION. THE PATIENT COMPLAINED OF PERSISTENT PAIN AND LOSS OF MOTION IN HIS LEFT HALLUX (BIG TOE) WHERE THE REFLEXION IMPLANT WAS PLACED IN 2010. THE SECOND DOCTOR EXPLANTED THE PART ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94200 METATARSAL HEAD LONG OR METATARSAL HEAL XLONG REFLEXION LZJ OSTEOMED UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention