BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN ILIZAROV EXFIX DEV

    MDR report key: 13636228 · Received March 1, 2022

    Report

    Report Number
    1020279-2022-00937
    Event Type
    Injury
    Date Received
    March 1, 2022
    Date of Event
    January 28, 2020
    Report Date
    April 5, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). SIGMUND, I. K., FERGUSON, J., GOVAERT, G. A., STUBBS, D., & MCNALLY, M. A. (2020). COMPARISON OF ILIZAROV BIFOCAL, ACUTE SHORTENING AND RELENGTHENING WITH BONE TRANSPORT IN THE TREATMENT OF INFECTED, SEGMENTAL DEFECTS OF THE TIBIA. JOURNAL OF CLINICAL MEDICINE, 9(2), 279. DOI: 10.3390/JCM9020279.

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT THE LITERATURE ARTICLE WAS REVIEWED. THE IMAGES PROVIDED IN THE ARTICLE HAVE BEEN INTERPRETED WITHIN THE TEXT; THEREFORE, NO FURTHER ANALYSIS OF THE IMAGES IS REQUIRED. WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE COULD NOT BE CONFIRMED NOR CONCLUDED. HOWEVER, IT WAS NOTED VIA E-MAIL CORRESPONDENCE WITH ONE OF THE AUTHORS OF THE ARTICLE, THAT ¿THESE COMPLICATIONS ARE COMMON EVENTS RELATED TO INFECTION AND BONE HEALING IN THIS PATIENT COHORT. NONE ARE RELATED TO ANY SPECIFIC IMPLANT OR PRODUCT AND HAVE BEEN DESCRIBED IN VIRTUALLY EVERY TYPE OF EXTERNAL AND INTERNAL FIXATION DEVICE.¿ NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS AND/OR SOME POTENTIAL PROBABLE CAUSES THAT COULD CONTRIBUTE TO THE REPORTED EVENT HAVE BEEN IDENTIFIED AS OVERUSE OR EXCESSIVE PRESSURE ON THE JOINT, INJURY, CONTAMINATION, PATIENT REACTION, POST-OPERATIVE HEALING ISSUE AND/OR PATIENT CONDITION. 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 PRODUCT 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

    IT WAS REPORTED THAT ON LITERATURE REVIEW "COMPARISON OF ILIZAROV BIFOCAL, ACUTE SHORTENING AND RELENGTHENING WITH BONE TRANSPORT IN THE TREATMENT OF INFECTED, SEGMENTAL DEFECTS OF THE TIBIA", FROM THE 47 PATIENTS IN THE SAMPLE USING ILIZAROV, IN TOTAL 30 PATIENTS HAD REVISION SURGERIES. TWENTY-FOUR (24) PATIENTS REQUIRED REVISION SURGERY. SEVENTEEN (17) PATIENTS DURING EXTERNAL FIXATION TREATMENT: ONE (1) HAD A FIBULAR DIVISION, FOUR (4) A BONE GRAFTING, THREE (3) A FRESHENING OF DOCKING SITE, FOUR (4) A DOCKING SITE REALIGNMENT, TWO (2) A RE-CORTICOTOMY DUE TO PREMATURE FUSION OF THE LENGTHENING SITE, TWO (2) A BONE MORPHOGENETIC PROTEIN ONLY AND ONE (1) A TETHERED PIN SITE RELEASE DUE TO PAIN. AND, SIX (6) PATIENTS AFTER THE ILIZAROV EXTERNAL FIXATION REMOVAL: ONE (1) A EXTERNAL FIXATION REAPPLICATION, FOUR (4) AN INTRAMEDULLARY NAIL, AND TWO (2) AN ANKLE FUSION. IN ADDITION, SIX (6) PATIENTS ALSO REQUIRED A REVISION SURGERY AFTER THE ILIZAROV EXTERNAL FIXATION REMOVAL, FOUR (4) HAD A PLATE REMOVAL ONLY, ONE (1) A PLATING AND BONE GRAFTING, ONE (1) A PLATING AND BONE MORPHOGENETIC PROTEIN. ALSO, FROM THOSE PATIENTS, TWENTY-TWO (22) PATIENTS SUFFERED AT LEAST ONE SUPERFICIAL PIN INFECTION REQUIRING TREATMENT WITH ORAL ANTIBIOTICS. PATIENT'S OUTCOME IS UNKNOWN. FURTHER INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390040 UNKN ILIZAROV EXFIX DEV PIN, FIXATION, THREADED JDW SMITH & NEPHEW, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H