BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4719231 · Received April 22, 2015

    Report

    Report Number
    2520274-2015-13300
    Event Type
    Injury
    Date Received
    April 22, 2015
    Report Date
    March 31, 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. HAKIMI, M., JUNGBLUTH, P., WINDOLF, J. AND WILD, M. FUNCTIONAL RESULTS AND COMPLICATIONS FOLLOWING LOCKING PALMAR PLATING ON THE DISTAL RADIUS: A RETROSPECTIVE STUDY. THE JOURNAL OF HAND SURGERY, 35E, 4, 283-288, 2010. THIS REPORT IS FOR UNKNOWN - LDR DISTAL RADIUSPLATE 2.4 SYSTEM/UNKNOWN QUANTITY/UNKNOWN LOT. (B)(4). 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE, HAKIMI, M., JUNGBLUTH, P., WINDOLF, J. AND WILD, M. FUNCTIONAL RESULTS AND COMPLICATIONS FOLLOWING LOCKING PALMAR PLATING ON THE DISTAL RADIUS: A RETROSPECTIVE STUDY. THE JOURNAL OF HAND SURGERY, 35E, 4, 283-288, 2010. 89 ADULT PATIENTS (59 WOMEN, 30 MEN; AVERAGE AGE 62 RANGE 18-94) WITH A DORSALLY DISPLACED DISTAL RADIUS FRACTURE WERE TREATED USING A SYNTHES LDR DISTAL RADIUSPLATE 2.4 OR A COMPETITORS LOCKING PALMAR PLATE. AT THE FINAL RADIOLOGICAL EXAMINATION ALL FRACTURES HAD UNITED. 2 PATIENTS DEVELOPED A POSTOPERATIVE SUBCUTANEOUS INFECTION WHICH WAS SUCCESSFULLY TREATED NON-OPERATIVELY. 2 PATIENTS HAD A CARPAL TUNNEL SYNDROME MAKING A CARPAL TUNNEL RELEASE NECESSARY 2 DAYS POSTOPERATIVELY. 2 PATIENTS HAD A POSTOPERATIVE IRRITATION OF THE MEDIAN NERVE. 3 PATIENTS HAD A SIGNIFICANT LOSS OF POSITION OF THE DISTAL RADIUS FROM FIRST POSTOPERATIVE RADIOGRAPHS. 1 PATIENT COMPLAINED OF PAIN, MAKING IT NECESSARY TO REMOVE THE PLATE 14 WEEKS POSTOPERATIVELY. A COPY OF THE LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN - LDR DISTAL RADIUSPLATE 2.4 SYSTEM, AND REFERS 2 PATIENTS DEVELOPED A POSTOPERATIVE SUBCUTANEOUS INFECTION WHICH WAS SUCCESSFULLY TREATED NON-OPERATIVELY, 2 PATIENTS HAD A CARPAL TUNNEL SYNDROME MAKING A CARPAL TUNNEL RELEASE NECESSARY 2 DAYS POSTOPERATIVELY, 2 PATIENTS HAD A POSTOPERATIVE IRRITATION OF THE MEDIAN NERVE, 3 PATIENTS HAD A SIGNIFICANT LOSS OF POSITION OF THE DISTAL RADIUS FROM FIRST POSTOPERATIVE RADIOGRAPHS AND 1 PATIENT COMPLAINED OF PAIN, MAKING IT NECESSARY TO REMOVE THE PLATE 14 WEEKS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266777 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention