BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3800280 · Received May 8, 2014

    Report

    Report Number
    2520274-2014-11180
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 24, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. SOLOMAN, L. B., CALLARY, S. A., BOOPLAN, P. R. J. V. C., CHAKRABARTY, A., COSTI, J. J., & HOWIE, D. W. (2013). IMPACTION BONE GRAFTING OF SEGMENTAL BONE DEFECTS IN FEMORAL NON-UNIONS. ACTA ORTHOPAEDICA BELGICA. 79, 64-70. THIS REPORT IS FOR AN UNKNOWN SCREW. 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. 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. SOLOMAN, L. B., CALLARY, S. A., BOOPLAN, P. R. J. V. C., CHAKRABARTY, A., COSTI, J. J., & HOWIE, D. W. (2013). IMPACTION BONE GRAFTING OF SEGMENTAL BONE DEFECTS IN FEMORAL NON-UNIONS. ACTA ORTHOPAEDICA BELGICA. 79, 64-70. IMPACTION BONE GRAFTING SHOWS ENCOURAGING EARLY RESULTS AS A METHOD IMMEDIATELY RESTORING LEG LENGTH, WHILE ALLOWING WEIGHT-BEARING AS TOLERATED, IN THE TREATMENT OF LARGE SEGMENTAL FEMORAL DEFECTS AFTER FEMORAL SHAFT AND METAPHYSEAL NON-UNIONS. THE RESULTS AT TWO AND THREE YEARS FOLLOW-UP SUGGEST THAT IMPACTION BONE GRAFTING OFFERS AN EFFECTIVE ALTERNATIVE TO THE ESTABLISHED TECHNIQUES OF LONG BONE SEGMENTAL RECONSTRUCTION. THREE PATIENTS UNDERWENT IMPACTION BONE-GRAFTING TO MANAGE CRITICAL SEGMENTAL BONE LOSS IN FEMORAL NON-UNIONS. A (B)(6) FEMALE FELL AT HOME; SUSTAINING AN OSTEOPORIC LEFT SUPRACONDYLAR FEMORAL FRACTURE. SHE UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION WITH LESS INVASIVE STABILIZATION SYSTEM (LISS) PLATE (SYNTHES). AT 8 MONTHS POST-INJURY WITH FAILED FIXATION, NON-UNION AND VARUS COLLAPSE OF THE SUPRACONDYLAR REGION OF THE FEMUR AND BONY GAP OF 3 CENTIMETERS. SHE WAS UNABLE TO MOBILIZE AND WAS WHEELCHAIR BOUND. A (B)(6) FEMALE FELL AT HOME, SUSTAINING A LEFT SUPRACONDYLAR FEMORAL FRACTURE. SHE UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION WITH A LISS PLATE (SYNTHES). SHE DEVELOPED A MULTIFOCAL CRYPTOCOCCUS INFECTION AND STAPHYLOCOCCUS WARNEI INFECTION. AT THREE YEARS POST-INJURY SHE HAD NON-UNION OF THE FEMUR WITH A 7 CENTIMETER DEFECT AND WAS WHEELCHAIR BOUND. FOR BOTH CASES THE FAILED IMPLANT WAS REMOVED AND RADICAL DEBRIDEMENT WAS DONE TO THE NON-UNION SITE. BOTH PATIENTS WERE REVISED. THE PATIENT¿S RECOVERY WAS UNEVENTFUL WITHOUT COMPLICATION. TIME TO FULL WEIGHT BEARING RANGED FROM SIX WEEKS TO THREE MONTHS. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. TWO OF 4 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277878 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention