BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3884546 · Received June 19, 2014

    Report

    Report Number
    2520274-2014-11994
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    February 7, 2014
    Report Date
    June 3, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN LCP SCREW /UNKNOWN LOT. 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 ¿TREATMENT OF HUMERAL SHAFT ASEPTIC NONUNIONS IN ELDERLY PATIENTS WITH OPPOSITE STRUCTURAL ALLOGRAFT, BMP-7, AND MESENCHYMAL STEM CELLS.¿ CANTON, G., CHERUBINO, P., MURENA, L., SURACE, M.F., AND VULCANO, E. (2014, FEBRUARY, 4). HEALIO.COM/ORTHOPEDICS (SEARCH:20140124-26). AN 81-YEAR-OLD WOMAN PRESENTED 23 MONTHS AFTER HAVING A TRANSVERSE FRACTURE OF THE MID-DISTAL THIRD OF THE RIGHT HUMERAL SHAFT. HER MEDICAL HISTORY WAS SIGNIFICANT FOR HYPERTENSION, SEVERE STENOSIS OF THE SUPRA-AORTIC TRUNKS, CHRONIC RENAL INSUFFICIENCY, AND PULMONARY EMPHYSEMA. TWO YEARS PRIOR TO THE HUMERAL SHAFT FRACTURE, THE PATIENT HAD BEEN TREATED ELSE¬WHERE FOR A RIGHT-SIDED PROXIMAL HUMERAL FRACTURE THAT HEALED WITH A LOCKING PLATE. THE HUMERAL SHAFT NONUNION WAS OBSERVED ON SERIAL RADIOGRAPHS, ULTIMATELY RESULTING IN THE RUPTURE OF THE NAILS 15 MONTHS POSTOPERATIVELY. THE PATIENT UNDERWENT SURGERY TO TREAT THE HUMERAL SHAFT NONUNION. THE NONUNION SITE WAS FILLED WITH FRESH-FROZEN CADAVER BONE, BMP-7, AND BMAC AND STABILIZED WITH A SYNTHES LCP PLATE AND OPPOSITE TIBAL CORTICAL ALLOGRAFT. INTRAOPERATIVELY, A LONGITUDINAL INCOMPLETE FRACTURE OF THE DISTAL HUMERUS, MOST PROBABLY CAUSED BY COMPRESSION SCREW OVERTIGHTENING, WAS OBSERVED. THIS FRACTURE WAS TREATED WITH METAL CERCLAGES AND 2 MONTHS OF SPLINT IMMOBILIZATION. AT ABOUT 4 MONTHS POSTOPERATIVELY, THE NONUNION SITE HAD HEALED FULLY. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN LCP SCREW. THIS REPORT IS FOR 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360978 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention