BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4696999 · Received April 16, 2015

    Report

    Report Number
    2520274-2015-12941
    Event Type
    Injury
    Date Received
    April 16, 2015
    Report Date
    April 1, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN 2.4-MM LCP VOLAR COLUMN DISTAL RADIUS PLATE /UNKNOWN QUANTITY/UNKNOWN LOT. 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. CARPAL TUNNEL RELEASE, MILD CREPITATION OF THE FLEXOR DIGITOURM AND VOLAR SUBLUXATION OF THE RADIOCARPAL ARTICULATION. 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 LITERATURE ARTICLE LOZANO-CALDERON, S., SOUER, S., MUDGAL, C., JUPITER, J. AND RING, S. (2008). WRIST MOBILIZATION FOLLOWING VOLAR PLATE FIXATION OF FRACTURES OF THE FISTAL PART OF THE RADIUS. J BONE JOINT SURG AM,90, 1297-304. THE PURPOSE OF THIS PAPER IS TO COMPARE CLINICAL TRIAL MOBILIZATION OF THE WRIST JOINT WITHIN TWO WEEKS (EARLY MOTION) OR AT SIX WEEKS (LATE MOTION) AFTER VOLAR PLATE FIXATION OF A FRACTURE OF THE DISTAL PART OF THE RADIUS IN ORDER TO TEST THE NULL HYPOTHESIS THAT THERE ARE NO DIFFERENCES IN THE FLEXION-EXTENSION ARC THREE AND SIX MONTHS AFTER SURGERY. SIXTY PATIENTS WITH AN ISOLATED FRACTURE OF THE DISTAL PART OF THE RADIUS THAT WAS TREATED WITH A SINGLE, FIXED ANGLE VOLAR PLATE AND SCREWS WERE ENROLLED. THIRTY PATIENTS WERE RANDOMIZED TO THE EARLY MOTION GROUP, AND THIRTY WERE RANDOMIZED TO THE LATE MOTION GROUP. THREE AND SIX MONTHS AFTER SURGERY, PATIENTS UNDERWENT RANGE OF MOTION MEASUREMENTS, GRIP STRENGTH MEASUREMENTS, AND RADIOGRAPHIC EVALUATION. OUT OF SIXTY PATIENTS, (THIRTY-NINE WOMEN AND TWENTY-ONE MEN) WITH AN AVERAGE AGE OF FIFTY-THREE YEARS (RANGE, TWENTY-FIVE TO EIGHTY-THREE YEARS). THE EARLY MOTION GROUP COMPRISED ELEVEN MEN AND NINETEEN WOMEN WITH AN AVERAGE AGE OF FIFTY-FIVE YEARS. THE LATE MOTION GROUP COMPRISED TEN MEN AND TWENTY WOMEN WITH AN AVERAGE AGE OF FIFTY-ONE YEARS. FOR EARLY MOTION GROUP: ONE PATIENT HAD A CARPAL TUNNEL RELEASE FIVE MONTHS AFTER SURGERY. ONE PATIENT HAD MILD CREPITATION OF THE FLEXOR DIGITORUM PROFUNDUS TENDONS OVER THE PLATE. ONE PATIENT HAD SLIGHT POSTOPERATIVE VOLAR SUBLUXATION OF THE RADIOCARPAL ARTICULATION. FOR LATE MOTION GROUP: THREE PATIENTS HAD MILD CREPITATION OF THE FLEXOR DIGITORUM PROFUNDUS TENDONS OVER THE PLATE. ONE PATIENT HAD SLIGHT POSTOPERATIVE VOLAR SUBLUXATION OF THE RADIOCARPAL ARTICULATION. ONE PATIENT WHO UNDERWENT IMPLANT REMOVAL AT EIGHT MONTHS BECAUSE OF IRRITATION OF THE FIRST DORSAL COMPARTMENT TENDONS CAUSED BY A SCREW. THIS IS REPORT 1 OF 2 FOR COM#(B)(4). AN UNKNOWN 2.4-MM LCP VOLAR COLUMN DISTAL RADIUS PLATE AND REFERS TO FOLLOWING ADVERSE-EVENTS: FOR EARLY MOTION GROUP: ONE PATIENT HAD A CARPAL TUNNEL RELEASE FIVE MONTHS AFTER SURGERY. ONE PATIENT HAD MILD CREPITATION OF THE FLEXOR DIGITORUM PROFUNDUS TENDONS OVER THE PLATE. ONE PATIENT HAD SLIGHT POSTOPERATIVE VOLAR SUBLUXATION OF THE RADIOCARPAL ARTICULATION FOR LATE MOTION GROUP: THREE PATIENTS HAD MILD CREPITATION OF THE FLEXOR DIGITORUM PROFUNDUS TENDONS OVER THE PLATE. ONE PATIENT HAD SLIGHT POSTOPERATIVE VOLAR SUBLUXATION OF THE RADIOCARPAL ARTICULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254263 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention