BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - ELASTIC NAILS: TITANIUM

    MDR report key: 11787049 · Received May 6, 2021

    Report

    Report Number
    8030965-2021-03656
    Event Type
    Injury
    Date Received
    May 6, 2021
    Report Date
    April 12, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS FOR AN UNK - ELASTIC NAILS: TITANIUM/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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 AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: QUAN-ZHOU W., SHU-MING H., QI-XUN C., (2014) TITANIUM ELASTIC NAIL VERSUS PLATE-SCREW FIXATION FOR THE TREATMENT OF UPPER SEGMENT FRACTURES OF FEMORAL SHAFT IN CHILDREN, CHINA J ORTHOP TRAUMA VOLUME 27, NO. 10 , PAGES 1-6 (CHINA). THIS STUDY AIMS TO COMPARE COMPLICATIONS AND OUTCOME OF TITANIUM ELASTIC NAIL VERSUS PLATE-SCREW FIXATION FOR THE TREATMENT OF UPPER SEGMENT FRACTURES OF FEMORAL SHAFT IN CHILDREN. FROM JANUARY 2006 TO AUGUST 2012,A TOTAL OF 32 CHILDREN AGES 3 - 12 YEARS WITH MIDDLE AND UPPER SEGMENT FEMORAL FRACTURES WERE TREATED WITH TITANIUM ELASTIC NAIL (TEN) AND PLATE-SCREW FIXATION (PF).THESE PATIENTS WERE RANDOMLY SELECTED FOR TREATMENT WITH TITANIUM ELASTIC NAIL AND PLATE-SCREW FIXATION. IN THE TITANIUM ELASTIC NAIL GROUP , WHERE A TITANIUM ELASTIC NAIL (TEN) WAS USED, THERE WERE 19 PATIENTS, INCLUDING 11 MALES AND 8 FEMALES; THE AGES WERE 3 -11 YEARS OLD, WITH THE AVERAGE AGE BEING (6.9 ± 2.2) YEARS OLD. IN THE PLATE-SCREW FIXATION GROUP, WHERE A PLATE-SCREW (DCP/LCP) PLATE WERE USED, THERE WERE 13 PATIENTS, INCLUDING 9 MALES AND 4 FEMALES; THE AGES WERE 5 - 12 YEARS OLD, WITH THE AVERAGE AGE BEING (7.5 ± 2.1) YEARS OLD. THE FOLLOW-UP TIME OF THE TITANIUM ELASTIC NAIL GROUP WAS 15 - 48 MONTHS, WITH AN AVERAGE OF 25.3 MONTHS; THE FOLLOW-UP TIME OF THE PLATE-SCREW FIXATION GROUP WAS 13 - 36 MONTHS, WITH AN AVERAGE OF 21.6 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED: TITANIUM ELASTIC NAIL GROUP: 1 SUPERFICIAL INFECTION OF INCISION OCCURRED, WHICH WAS CURED AFTER DRESSING CHANGE. 2 NAIL TAIL IRRITATION, WHICH WAS CURED WHEN THE INTERNAL FIXATION WAS REMOVED AFTER FRACTURE HEALING. 2 PAIN AT THE SITE OF NAIL TAIL IMPLANTATION, WHICH AFFECTED KNEE JOINT FLEXION AND EXTENSION, AND WAS OBVIOUS IN 1 PATIENT, THE SYMPTOMS DISAPPEARED AFTER REMOVING THE INTRAMEDULLARY NAIL. 3 LIMB LENGTH INEQUALITY OCCURRED, AT THE LAST FOLLOW-UP. 1 ANGULATION DEFORMITY. 1 ROTATIONAL DEFORMITY. 1 POOR RESULT OF HIP JOINT FUNCTION RESULT. PLATE-SCREW FIXATION GROUP: 2 LIMB LENGTH INEQUALITY. THIS REPORT IS FOR AN UNKNOWN SYNTHES (DCP/LCP) PLATE AND UNKNOWN SYNTHES TITANIUM ELASTIC NAIL (TEN). THIS REPORT IS FOR (1) UNK - ELASTIC NAILS: TITANIUM. THIS REPORT IS 1 OF 3 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682867 UNK - ELASTIC NAILS: TITANIUM NAIL, FIXATION, BONE JDS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention