BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 7510823 · Received May 14, 2018

    Report

    Report Number
    8030965-2018-53733
    Event Type
    Injury
    Date Received
    May 14, 2018
    Report Date
    April 23, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS. ALL KNOWN PATIENT INFORMATION IS CAPTURED IN THE LITERATURE ARTICLE. DATE OF EVENT: THERE ARE MULTIPLE UNKNOWN EVENT DATES BETWEEN (B)(6) 2006 AND (B)(6) 2014. THIS REPORT IS FOR UNKNOWN TITANIUM ELASTIC NAILS/UNKNOWN LOTS. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBERS ARE UNKNOWN. IMPLANTATION AND EXPLANTATION DATES ARE UNKNOWN. COMPLAINANT PARTS ARE NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LU, D. ET AL, (2017), THE OUTCOMES OF PEDIATRIC FEMORAL SHAFT FRACTURES TREATED SURGICALLY BY DIFFERENT TYPES OF ORTHOPEDISTS. INJURY, INT. J. CARE INJURED. VOLUME 48, PAGES 548-551., CHINA. THE OBJECTIVE OF THIS STUDY WAS TO PROSPECTIVELY COMPARE THE CLINICAL AND RADIOGRAPHIC OUTCOMES OF CHILDREN FEMORAL SHAFT FRACTURES TREATED SURGICALLY BY PEDIATRIC ORTHOPEDISTS AND NON PEDIATRIC ORTHOPEDISTS. FROM MAY 2006 TO JUNE 2014, 88 CHILDREN WITH FEMORAL SHAFT FRACTURES WERE RANDOMIZED TO OPERATIVE STABILIZATION. 44 PATIENTS, 29 MALE AND 15 FEMALE WERE OPERATED ON BY PEDIATRIC ORTHOPEDISTS WITH AN AVERAGE AGE OF 8.5 ± 2.3 YEARS. 44 PATIENTS, 31 MALE AND 13 FEMALE WERE OPERATED ON BY NON-PEDIATRIC ORTHOPEDISTS WITH AN AVERAGE AGE OF 8.7 ± 2.6 YEARS. FOLLOW-UP VISITS WERE MADE AT TWO, FOUR, 2,4, 12, AND 24 WEEKS, AND THEN EVERY THREE MONTHS INTERVAL AFTER DISCHARGE. THE MEAN FOLLOW-UP PERIOD WAS 20.9 ± 4.5 MONTHS FOR GROUP A AND 20.0 ± 3.6 MONTHS FOR GROUP B. COMPLICATIONS WERE REPORTED AS FOLLOWS: TWO CHILDREN DEVELOPED A SAGITTAL PLANE ANGULATION LESS THAN 5 DEGREES AND ONE PATIENT HAD A CORONAL PLANE ANGULATION OF 6 DEGREES. DURING SURGERY, 4 FRACTURES FAILED IN GROUP A AND 11 FAILED IN GROUP B. NAIL-TIP IRRITATIONS OCCURRED IN 5 PATIENTS (3 CASES IN GROUP A AND 2 CASES IN GROUP B), WHICH WERE RESOLVED WITHOUT INTERVENTION OR EARLY HARDWARE REMOVAL. FOUR PATIENTS IN GROUP A HAD LIMB LENGTHENING AND 1 HAD LIMB SHORTENING LESS THAN 2 CM. 3 PATIENTS IN GROUP B HAD LIMB LENGTHENING. THIS REPORT IS FOR UNKNOWN SYNTHES TITANIUM ELASTIC NAILS (TEN). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353184 ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention