BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

    MDR report key: 3754777 · Received April 16, 2014

    Report

    Report Number
    2520274-2014-10894
    Event Type
    Injury
    Date Received
    April 16, 2014
    Report Date
    March 25, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN END CAP. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE. RADIUS-ONLY INTRAMEDULLARY NAILING FOR BOTH-BONES DIAPHYSEAL FOREARM FRACTURES IN CHILDREN; MUSTAFA ALNAIB; RAZVAN TARANU; SANDESH LAKKOL; EHAB ALDLYAMI; ILHAN ALCELIK; CHRISTOPHER TULLOCH; ACTA ORTHOP. BELG., 2011, 77, 458-463. THE ARTICLE IS ATTACHED TO THE MEDWATCH. THIS ARTICLE IS A RETROSPECTIVE REVIEW OF RADIUS-ONLY INTRAMEDULLARY NAILING (IMN) FOR BOTH-BONES DIAPHYSEAL FOREARM FRACTURES IN CHILDREN. BETWEEN (B)(6) 2004 AND (B)(6) 2008, 64 CHILDREN PRESENTED TO OUR UNIT WITH DIAPHYSEAL BOTH BONES FOREARM FRACTURES. OF THOSE, 29 CHILDREN FULFILLED ALL THE CRITERIA THAT MADE THEM SUITABLE FOR TREATMENT WITH RADIUS-ONLY IMN USING TEN (TITANIUM ELASTIC NAIL, SYNTHES, (B)(4)), IN ACCORDANCE WITH THE DEPARTMENT PRACTICE. CLINICAL NOTES AND RADIOGRAPHS OF THOSE 29 CHILDREN WERE REVIEWED RETROSPECTIVELY. THE FOLLOWING CLINICAL AND RADIOLOGICAL INFORMATION WAS EXTRACTED: SEX, AGE, SIDE, TYPE OF FRACTURE IN THE AO CLASSIFICATION, MODE OF REDUCTION, COMPLICATIONS, TIME TO CONSOLIDATION, FOLLOW-UP DURATION. OF THESE 29, THERE WERE 9 GIRLS AND 20 BOYS AND THE MEAN AGE AT THE TIME OF OPERATION WAS 9 YEARS (RANGE: 5 TO 17 YEARS). THERE WAS A (B)(6) GIRL IN THIS SERIES THAT WAS SKELETALLY IMMATURE WITH OPEN PHYSES THE DECISION WAS MADE TO TREAT HER INJURY AS A PEDIATRIC RATHER THAN AN ADULT FOREARM FRACTURE. ELEVEN PATIENTS HAD LEFT FOREARM INJURIES AND 18 HAD RIGHT FOREARM INJURIES. CLOSED REDUCTION WAS ACHIEVED IN 21 PATIENTS, WHILE 8 PATIENTS REQUIRED OPEN REDUCTION. ALL PATIENTS HAD RADIUS-ONLY IMN. ALL PATIENTS WERE REVIEWED REGULARLY AT 2 WEEKS, 6 WEEKS AND 4 MONTHS. THE FOREARM WAS IMMOBILIZED UNTIL THE FRACTURE HAD DEMONSTRATED CLINICAL AND RADIOLOGICAL SIGNS OF UNION. MEAN DURATION OF FINAL FOLLOW UP WAS 6.8 MONTHS (RANGE: 4 TO 12 MONTHS). OF THESE 29 PATIENTS, 6 PATIENTS HAD COMPLICATIONS. OF THESE 6, 2 PATIENTS REPORTED INFECTION, 2 HAD RE-FRACTURE, AND 2 HAD REDUCED SUPINATION. THIS REPORT IS FOR UNKNOWN END CAP. THIS IS REPORT 8 OF 12 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232768 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other