BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD,FIXATION,INTRAMEDULLARY

    MDR report key: 5886107 · Received August 18, 2016

    Report

    Report Number
    2520274-2016-14197
    Event Type
    Injury
    Date Received
    August 18, 2016
    Report Date
    July 28, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PRATA DO NASCIMENTO, F. ET AL (2013) FLEXIBLE INTRAMEDULLARY NAILS WITH TRACTION VERSUS PLASTER CAST FOR TREATING FEMORAL SHAFT FRACTURES IN CHILDREN: COMPARATIVE RETROSPECTIVE STUDY. SAO PAULO MED J. 131: 5-12. BRAZIL. THIS REPORT IS FOR UNKNOWN TITANIUM ELASTIC NAIL (TEN), UNKNOWN PART NUMBER, UNKNOWN LOT NUMBER, UNKNOWN QUANTITY. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: PRATA DO NASCIMENTO, F. ET AL (2013) FLEXIBLE INTRAMEDULLARY NAILS WITH TRACTION VERSUS PLASTER CAST FOR TREATING FEMORAL SHAFT FRACTURES IN CHILDREN: COMPARATIVE RETROSPECTIVE STUDY. SAO PAULO MED J. 131: 5-12. BRAZIL. THE PURPOSE OF THIS STUDY IS TO COMPARE TREATMENTS FOR FEMORAL SHAFT FRACTURES USING INTRAMEDULLARY NAILS (TITANIUM ELASTIC NAILS (TEN)) VERSUS TRACTION AND PLASTER CASTS IN CHILDREN. THIS RETROSPECTIVE COMPARATIVE STUDY CONSISTED OF 60 CHILDREN WITH FEMORAL FRACTURES: 30 UNDERWENT SURGICAL TREATMENT WITH TEN AND 30 WERE TREATED CONSERVATIVELY USING PLASTER CASTS. PATIENTS' AGES RANGED FROM 5 TO 13.5 YEARS, 41 MALES AND 19 FEMALES. FRACTURES WERE TRANSVERSE AND OBLIQUE. FOLLOW UPS CONSISTED OF PHYSICAL EXAMINATION, RADIOGRAPHS, AND SCANOMETRY. ANGULAR DEFORMITIES (IN DEGREES), DISCREPANCIES (IN CENTIMETERS), INITIAL AND FINAL SHORTENING AND EXCESSIVE GROWTH WERE MEASURED. OTHER VARIABLES WERE ALSO ANALYZED: DURATION OF TRACTION AND HOSPITALIZATION, TIME TAKEN FOR THE PATIENT TO BE ABLE TO BEAR WEIGHT ON THE LIMB AND RETURN TO HIS DAILY ACTIVITIES, TIME TAKEN FOR CONSOLIDATION TO BE ACHIEVED, PRESENCE OF ACUTE AND LATE COMPLICATIONS, NUMBER OF SUBSEQUENT HOSPITALIZATIONS, COMPLAINTS AND LENGTH OF FOLLOW-UP. COMPARISONS WERE MADE USING THE FISHER, MANN-WHITNEY TESTS, BARLETT AND PEARSON CHISQUARE TEST. ANALYSIS OF VARIANCE (ANOVA) WAS ALSO USED. THE MINIMUM LENGTH OF FOLLOW-UP WAS 24 MONTHS. FREQUENCY OF FOLLOW-UPS WAS NOT SPECIFIED. BETWEEN SIX AND EIGHT MONTHS AFTER FRACTURE HEALING AND REMODELING, NAILS WERE SURGICALLY REMOVED. THE FOLLOWING COMPLICATIONS WERE REPORTED: PATIENT PRESENTED MIGRATION OF THE NAIL. PATIENT UNDERWENT REVISION SURGERY TO CUT TIP OF THE NAIL. ADDITIONAL COMPLICATIONS WERE PROVIDED FOR CONSERVATIVE GROUP BUT THEY WILL NOT BE ASSESSED IN THIS REPORT. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS REPORT IS FOR UNKNOWN TITANIUM ELASTIC NAIL (TEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538963 ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention