BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TAYLOR SPATIAL FRAME EXFIX DEV

    MDR report key: 10034207 · Received May 7, 2020

    Report

    Report Number
    1020279-2020-01522
    Event Type
    Injury
    Date Received
    May 7, 2020
    Date of Event
    April 15, 2020
    Report Date
    August 7, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: IT WAS REPORTED FROM A LITERATURE REVIEW THAT THE PATIENT HAD LARGE BONE DEFECTS. THE AFFECTED COMPLAINT DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. THEREFORE A PRODUCT ANALYSIS COULD NOT BE PERFORMED. AS DEVICE INFORMATION WAS NOT MADE AVAILABLE, DEVICE HISTORY RECORD AND COMPLAINT HISTORY REVIEW CANNOT BE COMPLETED. THERE IS NO INFORMATION THAT WOULD SUGGEST THE DEVICE FAILED TO MEET SPECIFICATIONS. A RELATIONSHIP, IF ANY, BETWEEN THE DEVICE AND THE REPORTED INCIDENT COULD NOT BE CORROBORATED. NO MEDICAL DOCUMENTS WERE RECEIVED FOR INVESTIGATION. THEREFORE NO MEDICAL ASSESSMENT CAN BE PERFORMED AT THIS TIME. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SOME POTENTIAL CAUSES COULD INCLUDE BUT ARE NOT LIMITED TO PATIENT REACTION, TRAUMA INJURY OR PATIENT MEDICAL CONDITIONS. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED AND NO PATIENT MEDICAL RECORDS AVAILABLE, OUR INVESTIGATION OF THIS REPORT IS INCONCLUSIVE. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    "BONE TRANSPORT FOR POSTINFECTIOUS SEGMENTAL TIBIAL BONE DEFECTS WITH A COMBINED ILIZAROV/TAYLOR SPATIAL FRAME TECHNIQUE". AUTHOR: F. SALA ET AL., IN THIS STUDY, TWELVE PATIENTS WITH ATROPHIC TIBIAL NON-UNIONS WERE TREATED WITH RESECTION OF THE NONUNION FOLLOWED BY BONE TRANSPORT USING THE TSF FOR THE SEGMENTAL TIBIAL BONE DEFECTS. ALL PATIENTS WERE TREATED BY THE SAME SURGEON (F.S.). IT WAS DOCUMENTED ON THE PAPER THAT THREE PATIENTS HAD LARGE BONE DEFECTS (7.0, 6.8, AND 10.0 CM, RESPECTIVELY) HAD MINIMAL REGENERATE BENDING (LESS THAN 5 GRADES); THESE WERE TREATED WITH BIFOCAL TRANSPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496218 UNKNOWN TAYLOR SPATIAL FRAME EXFIX DEV PIN, FIXATION, THREADED JDW SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R