BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN TAYLOR SPATIAL FRAME EXFIX DEV

    MDR report key: 10033935 · Received May 7, 2020

    Report

    Report Number
    1020279-2020-01520
    Event Type
    Injury
    Date Received
    May 7, 2020
    Date of Event
    April 15, 2020
    Report Date
    January 4, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INFORMATION RECEIVED BY THE MANUFACTURER HAS IDENTIFIED THAT THIS EVENT SHOULD BE RE-EVALUATED FOR MDR REPORTING. THE NEW INFORMATION STATES THAT THE BENDING WAS OBSERVED CLINICALLY AND RADIOGRAPHICALLY; HOWEVER, NONE OF THESE PATIENTS DEVELOPED PROGRESSIVE DEFORMITY NECESSITATING SURGICAL INTERVENTION. THEREFORE, IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED. CORRECTED DATA: B4

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE DEVICES WERE NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, THESE COMPLAINT ARE FROM A LITERATURE REVIEW FROM 2011. "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. NO PATIENT SPECIFIC CLINICAL/MEDICAL INFORMATION WAS AVAILABLE. IF ADDITIONAL SUPPORTING MEDICAL DOCUMENTS ARE RECEIVED THIS COMPLAINT WILL BE REASSESSED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCTS FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. SOME POTENTIAL CAUSES COULD INCLUDE BUT ARE NOT LIMITED TO PATIENT REACTION, TRAUMA INJURY OR PATIENT MEDICAL CONDITIONS. THE CONTRIBUTION OF THE DEVICES TO THE REPORTED EVENT COULD NOT BE CORROBORATED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE RETURN OF THE ACTUAL PRODUCTS INVOLVED, OUR INVESTIGATION COULD NOT PROCEED. SHOULD THE DEVICES OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    "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 TREATED WITH BIFOCAL TRANSPORT FOR LARGE DEFECTS (7.0, 6.8, AND 10.0 CM, RESPECTIVELY) HAD MINIMAL REGENERATE BENDING (LESS THAN 5). IN THESE PATIENTS, THE BENDING WAS OBSERVED CLINICALLY AND RADIOGRAPHICALLY; HOWEVER, NONE OF THESE PATIENTS DEVELOPED PROGRESSIVE DEFORMITY NECESSITATING SURGICAL INTERVENTION.

    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
    499427 UNKN TAYLOR SPATIAL FRAME EXFIX DEV PIN, FIXATION, THREADED JDW SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R