BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - ELASTIC NAILS: TITANIUM

    MDR report key: 11771588 · Received May 4, 2021

    Report

    Report Number
    8030965-2021-03553
    Event Type
    Injury
    Date Received
    May 4, 2021
    Report Date
    April 8, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. THIS REPORT IS FOR AN UNKNOWN TITANIUM ELASTIC NAIL/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS BETWEEN (B)(6) 2005 AND (B)(6) 2007. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: EL-ADL, G. ET AL. (2009), TITANIUM ELASTIC NAIL FIXATION FOR PAEDIATRIC FEMORAL AND TIBIAL FRACTURES, ACTA ORTHOPAEDICA BELGICA, VOL. 75, PAGES 512-520 (SAUDI ARABIA). THE AIM OF THIS PROSPECTIVE STUDY WAS TO EVALUATE THE RESULTS OF TREATMENT OF PAEDIATRIC FEMORAL AND/OR TIBIAL DIAPHYSEAL FRACTURES WITH TITANIUM ELASTIC NAILS (TENS). BETWEEN DECEMBER 2005 AND DECEMBER 2007, 66 PATIENTS WITH 73 FRACTURES (48 FEMORAL AND 25 TIBIAL) WERE TREATED WITH 2 TENS. THERE WERE 48 MALE (72.7%) AND 18 FEMALE (27.3%) PATIENTS. MEAN AGE AT TIME OF INJURY WAS 9.4 YEARS (RANGE:5.2 TO 15.3 YEARS). ALL PATIENTS WERE FOLLOWED-UP CLINICALLY EVERY 2 TO 3 WEEKS FOR ASSESSMENT OF HIP, KNEE AND ANKLE RANGE OF MOTION AND ANY COMPLICATIONS TILL COMPLETE BONE HEALING, THEN EVERY 3 MONTHS TILL THE END OF THE FOLLOW-UP PERIOD, WHICH WAS AT LEAST 12 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 16 COMPLICATIONS WERE NOTED IN 16.6% OF PATIENTS. MOST OF THESE COMPLICATIONS WERE TRANSIENT AND RESOLVED COMPLETELY WITHOUT AFFECTING THE FUNCTIONAL OUTCOME AND WITHOUT REQUIRING ANY SURGICAL INTERFERENCE OR READMISSION. 9.1% OF PATIENTS HAD SOFT TISSUE IRRITATION IN RELATION TO THE ENDS OF THE TENS AT THE ENTRY POINTS 6% OF PATIENTS HAD LIMB LENGTHENING. 2 PATIENTS AHD LIMB-SHORTENING. 1 COMMINUTED FEMORAL FRACTURE HEALED WITH AN 8° VARUS ANGULATION, AND ANOTHER COMMINUTED FEMORAL FRACTURE WITH A 10° VALGUS ANGULATION. ANOTHER COMMINUTED FEMORAL FRACTURE HEALED WITH A 5° FLEXION ANGULATION. THIS REPORT IS FOR AN UNKNOWN SYNTHES TEN. THIS REPORT IS FOR ONE (1) TITANIUM ELASTIC NAIL. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666347 UNK - ELASTIC NAILS: TITANIUM NAIL, FIXATION, BONE JDS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention