BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3982269 · Received August 5, 2014

    Report

    Report Number
    2520274-2014-12726
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    December 7, 2011
    Report Date
    July 4, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. A PROSPECTIVE RANDOMIZED TRIAL COMPARING NONOPERATIVE TREATMENT WITH VOLAR LOCKING PLATE FIXATION FOR DISPLACED AND UNSTABLE DISTAL RADIAL FRACTURES IN PATIENTS SIXTY-FIVE YEARS OF AGE AND OLDER. ROHIT ARORA, MD, ET AL (2011). THE JOURNAL OF BONE AND JOINT SURGERY, INCORPORATED, 93:2146-53. THIS DEVICE IS FOR UNKNOWN SCREW/UNKNOWN SCREW/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.

    Additional Manufacturer Narrative · 1

    DEVICE USE FOR TREATMENT NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4)

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: A PROSPECTIVE RANDOMIZED TRIAL COMPARING NONOPERATIVE TREATMENT WITH VOLAR LOCKING PLATE FIXATION FOR DISPLACED AND UNSTABLE DISTAL RADIAL FRACTURES IN PATIENTS SIXTY-FIVE YEARS OF AGE AND OLDER. ROHIT ARORA, MD, ET AL (2011). THE JOURNAL OF BONE AND JOINT SURGERY, INCORPORATED, 93:2146-53. THIS WAS A RETROSPECTIVE STUDY THAT REVIEWED 36 PATIENTS TREATED WITH OPEN REDUCTION INTERNAL FIXATION WITH A VOLAR LOCKING PLATE. FOUR OF THE PATIENTS WERE TREATED WITH VOLAR FIXED-ANGLE PLATE (2.4-MM LCP DRP [SYNTHES, (B)(4]), WHILE THE REMAINING PATIENTS WERE TREATED WITH COMPETITOR DEVICES. 13 OF THE 36 PATIENTS HAD COMPLICATIONS. NO BREAKAGE OF PLATES WERE OBSERVED. 2 PATIENTS HAD PAIN DUE TO TYPE-1 COMPLEX REGIONAL PAIN SYNDROME. IMPLANTS WERE NOT REMOVED. THIS IS REPORT 4 OF 4 FOR (B)(4). THIS REPORT IS FOR UNKNOWN SCREWS AND PLATES. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR 2 DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456999 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention