BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3905102 · Received July 1, 2014

    Report

    Report Number
    2520274-2014-12044
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    December 28, 2010
    Report Date
    June 12, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN CANNULATED SCREWS/UNKNOWN QUANTITIES/UNKNOWN LOT. 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 ARTICLE. PERCUTANEOUS ILIOSACRAL SCREW FIXATION IN S1 AND S2 FOR POSTERIOR PELVIC RING INJURIES: TECHNIQUE AND PERIOPERATIVE COMPLICATIONS. OSTERHOFF G., OSSENDORF C., WANNER G.A., SIMMEN H.P., WERNER C.M.L. (2011) ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY. 131, VOL 6, 809-813. THIS IS A RETROSPECTIVE STUDY OF 38 PATIENTS WITH PELVIC RING INSTABILITIES WHO UNDERWENT PERCUTANEOUS ILIOSACRAL FIXATION USING CANNULATED SCREWS (SYNTHES, (B)(4)). TWENTY-ONE PATIENTS UNDERWENT UNILATERAL AND 17 PATIENTS UNDERWENT BILATERAL SCREW FIXATION BETWEEN 10/2008 ¿ 03/2010. SECONDARY SURGERY DUE TO SCREW MALPOSITIONING OR LOOSENING HAD TO BE PERFORMED IN FOUR PATIENTS. ONE PATIENT PRESENTED WITH NON-UNION, 13 MONTHS AFTER SURGERY. IN THE PRESENT STUDY, THE PROCEDURE USING STANDARD C-ARM FLUOROSCOPY WAS FOUND TO BE SAFE IN THE HANDS OF SURGEONS ACQUAINTED WITH KNOWLEDGE OF THE PELVIC ANATOMY AND ITS FLUOROSCOPIC CORRELATIONS. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT REFERS TO UNKNOWN CANNULATED SCREWS AND THE SECONDARY SURGERY DUE TO SCREW MALPOSITIONING OR LOOSENING. THIS REPORT IS FOR 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384935 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention