BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3894736 · Received June 25, 2014

    Report

    Report Number
    2520274-2014-12063
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    June 5, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. LEE, S.K., SEO, D.W., KIM, K.J., YANG, D.S., CHOY, W.S. VOLAR LONG LOCKING COMPRESSION PLATE FIXATION FOR DISTAL RADIUS FRACTURES WITH METAPHYSEAL AND DIAPHYSEAL EXTENSION; EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY AND TRAUMATOLOGY (2013) 23:407-415. THIS REPORT IS FOR AN UNKNOWN COMPACT HAND PLATE. 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: LEE, S.K., SEO, D.W., KIM, K.J., YANG, D.S., CHOY, W.S. VOLAR LONG LOCKING COMPRESSION PLATE FIXATION FOR DISTAL RADIUS FRACTURES WITH METAPHYSEAL AND DIAPHYSEAL EXTENSION; EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY AND TRAUMATOLOGY (2013) 23:407-415. THIS RETROSPECTIVE STUDY WAS PERFORMED BETWEEN SEPTEMBER 2006 AND AUGUST 2010 FOR 20 PATIENTS (8 MALE/12 FEMALE) WHO UNDERWENT SURGICAL TREATMENT FOR A COMMINUTED DISTAL RADIAL FRACTURE THAT EXTENDED FROM THE DISTAL PART OF THE RADIUS TO INVOLVE THE DIAPHYSIS PROXIMALLY WITH APPLICATION OF A 2.4-MM-EXTRA-LONG LOCKING COMPRESSION PLATE (LCP) VOLAR DISTAL RADIUS PLATE (SYNTHES USA). THE PURPOSE OF THE STUDY WAS TO EVALUATE THE RADIOGRAPHIC AND FUNCTIONAL OUTCOMES OF TREATMENT WITH VOLAR LONG LCP SYSTEM FOR DISTAL RADIUS FRACTURES WITH METAPHYSEAL AND DIAPHYSEA EXTENSION. PLATES ARE TITANIUM ALLOY OR STAINLESS STEEL, LENGTH WAS 100, 120 OR 140MM, HEIGHT OF 2MM, HEAD OF PLATE HAS FOUR HOLES FOR 2.4-MM LOCKING SCREW AND SHAFT HAS 8, 10 OR 12 HOLES FOR 2.4-MM LOCKING OR 2.7-MM CORTICAL SCREW. THE DISTAL SCREWS ARE DIRECTED TOWARD THE ARTICULAR SURFACE. THE DIVERGING PLATE SCREWS BUTTRESS THE DISTAL RADIUS AND ALLOW FOR THE SECURING OF THE STYLOID THAT IS DISPLACED DORSALLY AND HARD TO REACH FRAGMENTS THAT ARE CLOSE TO THE JOINT (SYNTHES USA). INCISION IS MADE TO EXPOSE THE FRACTURE SITE, TRACTION WAS MAINTAINED UNDER FLUOROSCOPIC GUIDANCE USING TEMPORARY K-WIRE FIXATION OF DISTAL RADIOULNAR JOINT (DRUJ) UNTIL PLATE WAS APPLIED. SCREW WAS INSERTED IN AN ELONGATED LCP COMBI-HOLE FIRST, AND THE LOCKING HEAD SCREW WAS INSERTED INTO THE PROXIMAL HOLE OF THE PLATE SHAFT. ALL DISTAL SCREWS WERE INSERTED ONTO THE DORSAL CORTEX THEN K-WIRE WAS REMOVED. THERE WERE FIVE CASES OF COMBINED DISPLACED ULNAR NECK FRACTURE STABILIZED WITH A LCP COMPACT HAND (SYNTHES USA). FOURTEEN PATIENTS WITH LARGE METAPHYSEAL DEFECT UNDERWENT ADJUNCTIVE BONE GRAFTING OR CALCIUM PHOSPHATE CEMENTING. SATISFACTORY REDUCTION AND FRACTURE HEALING WERE ACHIEVED IN ALL CASES. COMPLICATIONS INCLUDED: IMPLANT FAILURE, INFECTION, SOFT TISSUE COMPROMISE, DIGITAL STIFFNESS AND DELAYED UNION. ONE PATIENT HAD PARESTHESIA WHICH RESOLVED SPONTANEOUSLY AFTER THREE MONTHS. TWO YEARS AFTER SURGERY FIVE WRISTS SHOWED MILD ARTHRITIC CHANGES. FIVE PLATES WERE REMOVED AT PATIENT¿S REQUEST. THIS IS REPORT TWO OF TWO FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371872 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention