BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MW5080358

    MDR report key: 7934438 · Received October 3, 2018

    Report

    Report Number
    MW5080358
    Event Type
    Injury
    Date Received
    October 3, 2018
    Date of Event
    August 8, 2018
    Report Date
    August 28, 2018
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ENROLLED IN A SINGLE-BLIND RANDOMIZED TRIAL, THE NF PROTOCOL 107: A STUDY OF INFUSE BONE GRAFT IN THE TREATMENT OF TIBIAL PSEUDARTHROSIS IN NEUROFIBROMATOSIS I (NFI) STUDY, AND RANDOMIZED TO ONE OF THE STUDY TREATMENT GROUP, BMP-2 OR CONTROL, ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT UNDERWENT REPAIR OF HIS CONGENITAL PSEUDOARTHROSIS OF THE TIBIA WITH ILIAC CREST HARVEST AND BONE GRAFTING. THE ROD PLACED WAS A RUSH ROD ALONG WITH THE RANDOMIZED STUDY TREATMENT DEVICE AND DETERMINED THAT IT WAS IN THE CORRECT POSITION BY X-RAY. THE PATIENT RETURNED TO THE OUTPATIENT CLINIC FOR HIS FIRST POST-OPERATIVE FOLLOW-UP ON (B)(6) 2015. IT WAS AT THIS VISIT THAT THE ROD BACKED OUT AND LOST FIXATION. HOWEVER, THIS EVENT WAS NOT RELATED TO THE STUDY DEVICE BUT CONSIDERED AS A EXPECTED RISK OF THE SURGICAL PROCEDURE. IN ADDITION, THE STUDY TREATMENT DEVICE WAS NOT AFFECTED. SURGICAL INTERVENTION WAS DONE TO REVISE THE ROD ON THE LEFT TIBIA ON (B)(6) 2018. IT WAS DETERMINED UNDER X-RAY THAT THE ROD WAS TAMPED DOWN DEEP INTO THE CALCANEUS WHERE IT WAS CONFIRMED THAT THE HOOK WAS COMPLETELY IMBEDDED WITH THE CALCANEUS AND SIGNIFICANT IMPROVEMENT IN STABILITY WAS NOTED. IT WAS DETERMINED IT WAS IN AN ACCEPTABLE POSITION BY X-RAY. THIS PROCEDURE WAS AN OUTPATIENT PROCEDURE AND THE PATIENT WAS DISCHARGED THAT SAME DAY. ON (B)(6) 2018, THE PATIENT RETURNED TO THE OUTPATIENT CLINIC FOR A POST-OPERATIVE VISIT. IT WAS AGAIN DETERMINED THAT THE ROD BACKED OUT AND LOST FIXATION AGAIN ON X-RAY. AGAIN, THIS EVENT WAS UNRELATED WHETHER OR NOT THE PATIENT RECEIVED THE STUDY DEVICE AND WAS AN EXPECTED COMPLICATION TO THE SURGERY. AN ORTHOPEDIC SURGEON FROM ANOTHER PARTICIPATING SITE, (B)(6), WAS CONSULTED AND THE PATIENT WAS REFERRED TO THIS SITE. THE FAMILY AND THE PATIENT DECIDED TO PROCEED WITH THIS TO HAVE THE ROD REVISED USING A WILLIAMS ROD PLACED. THE WILLIAMS ROD WAS NOT AVAILABLE AT (B)(6). THE SURGERY WAS SCHEDULED AND PERFORMED THE SECOND REVISION OF THE ROD ON (B)(6) 2018 AT (B)(6) HOSPITAL. THE PATIENT WILL HAVE A FOLLOW-UP IN 6 WEEKS WITH DR (B)(6). THIS EVENT IS STILL ONGOING UNTIL THE FIXATION AND HEALING HAS BEEN DETERMINE.

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization