BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD,FIXATION,INTRAMEDULLARY

    MDR report key: 7495030 · Received May 8, 2018

    Report

    Report Number
    8030965-2018-53618
    Event Type
    Injury
    Date Received
    May 8, 2018
    Report Date
    April 18, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. DATE OF EVENT IS UNKNOWN. THIS REPORT IS FOR TITANIUM ELASTIC NAIL SYSTEM. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER CONTACT NUMBER WAS NOT PROVIDED. THIS REPORT IS FOR TITANIUM ELASTIC NAIL SYSTEM. PMA/510(K) NUMBER IS NOT AVAILABLE. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    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: CANAVESE, F. ET AL. (2017) OUTCOME OF CONSERVATIVE VERSUS SURGICAL TREATMENT OF HUMERAL SHAFT FRACTURE IN CHILDREN AND ADOLESCENTS: COMPARISON BETWEEN NONOPERATIVE TREATMENT (DESAULT¿S BANDAGE), EXTERNAL FIXATION AND ELASTIC STABLE INTRAMEDULLARY NAILING. J PEDIATR ORTHOP. VOLUME 37, NO. 3, PAGES E156-E163. ((B)(6)) THIS STUDY RETROSPECTIVELY EVALUATES THE CLINICAL AND RADIOGRAPHIC OUTCOMES OF DISPLACED HUMERAL SHAFT FRACTURES IN CHILDREN AND ADOLESCENTS TREATED BY DESAULT¿S BANDAGE, EXTERNAL FIXATION, AND ELASTIC STABLE INTRAMEDULLARY NAILING (ESIN), AND TO EVALUATE UPPER EXTREMITY FUNCTION WITH THE SHORT VERSION OF THE DISABILITIES OF THE ARM, SHOULDER AND HAND OUTCOME QUESTIONNAIRE. FROM SEPTEMBER 2010 TO MAY 2014, 36 CHILDREN WITH HUMERAL SHAFT FRACTURES WERE RECORDED, OF WHICH 15 (12 MALES AND 3 FEMALES WITH MEAN AGE OF 12.7 ± 2.2 YEARS) UNDERWENT SURGICAL TREATMENT WITH AN UNKNOWN SYNTHES TITANIUM ELASTIC NAIL SYSTEM. ALL PROCEDURES WERE PERFORMED UNDER GENERAL ANESTHESIA. ONCE CLOSED REDUCTION WAS ACHIEVED, EACH FRACTURE WAS TREATED USING TWO (2) TITANIUM FLEXIBLE NAILS OF THE SAME DIAMETER. CLINICAL FOLLOW-UP FOR AT LEAST 12 MONTHS. COMPLICATIONS WERE REPORTED AS FOLLOWS: ONE PATIENT SUSTAINED A FALL AND DEVELOPED SECONDARY DISPLACEMENT 10 DAYS AFTER INDEX SURGERY. THIS PATIENT UNDERWENT HARDWARE REMOVAL, CLOSED REDUCTION AND FRACTURE STABILIZATION BY ESIN. AFTER REDUCTION, A SPLINT WAS APPLIED TO IMMOBILIZE THE UPPER EXTREMITY FOR FOUR WEEKS. THE PATIENT WAS ALLOWED TO RESUME FULL PHYSICAL AND SPORT ACTIVITIES SIX MONTHS AFTER THE LAST REDUCTION. ONE PATIENT HAD A RE-FRACTURE AND ANOTHER PATIENT HAD AN INFECTION. THIS REPORT IS FOR UNKNOWN TITANIUM ELASTIC NAIL SYSTEM. THIS IS REPORT 1 OF 1 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337286 ROD,FIXATION,INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention