BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4694351 · Received April 15, 2015

    Report

    Report Number
    2520274-2015-12889
    Event Type
    Injury
    Date Received
    April 15, 2015
    Report Date
    March 27, 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. ARORA, R., ET AL. (2010). INITIAL SHORTENING AND INTERNAL FIXATION IN COMBINATION WITH A SAUVE-KAPANDJI PROCEDURE FOR SEVERELY COMMINUTED FRACTURES OF THE DISTAL RADIUS IN ELDERLY PATIENTS. J BONE JOINT SURG 2010:92-B:1558-62. THIS REPORT IS FOR UNKNOWN SYNTHES 2.4MM LCP 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. 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

    LITERATURE ARTICLE RECEIVED: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, ARORA, R., ET AL. (2010). INITIAL SHORTENING AND INTERNAL FIXATION IN COMBINATION WITH A SAUVE-KAPANDJI PROCEDURE FOR SEVERELY COMMINUTED FRACTURES OF THE DISTAL RADIUS IN ELDERLY PATIENTS. J BONE JOINT SURG 2010:92-B:1558-62. A RETROSPECTIVE REVIEW OF THE RADIOLOGICAL AND CLINICAL RECORDS BETWEEN 1991 AND 2000 IDENTIFIED 11 WOMEN WITH A MEAN AGE OF 74 YEARS (65-81) WHO SUSTAINED AN UNSTABLE RADIAL FRACTURE IN ASSOCIATION WITH COMMINUTED DISTAL ULNAR FRACTURE AND WERE TREATED BY VOLAR PLATING OF THE RADIAL FRACTURE AND A PRIMARY SAUVE-KAPANDJI PROCEDURE. FIXATION WAS OBTAINED USING A VOLAR DISTAL RADIUS PLATE (KLS MARTIN, (B)(4)) IN SIX CASES AND A 2.4 MM LOCKING COMPRESSION PLATE (LCP) (SYNTHES, (B)(4)) IN FIVE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN SYNTHES 2.4MM LCP PLATE AND REFERS TO SIX PATIENTS HAD STAGE I AND TWO HAD STAGE 2 ARTHRITIS AT THE RADIOCARPAL JOINT, TWO PATIENTS HAD MILD AND TWO HAD MODERATE PAIN, ONE PATIENT DEVELOPED CARPAL TUNNEL SYNDROME, WHICH RESOLVED WITH PHYSIOTHERAPY. ANOTHER PATIENT DEVELOPED A COMPLEX REGIONAL PAIN SYNDROME AND CALCIFICATION BETWEEN THE ULNAR STUMPS WHICH RESULTED IN REMOVAL OF THE RADIAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250037 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention