BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3782081 · Received April 30, 2014

    Report

    Report Number
    2520274-2014-11076
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 16, 2014
    Manufacturer
    SYNTHES(USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    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. NORK, S., JONES, C., HARDING, S., MIRZA, S., AND ROUTT, JR., M.L. (2001). PERCUTANEOUS STABILIZATION OF U-SHAPED SACRAL FRACTURES USING ILIOSACRAL SCREWS: TECHNIQUE AND EARLY RESULTS. JOURNAL OF ORTHOPAEDIC TRAUMA, 15 (4), 238-246. THIS REPORT IS FOR AN UNKNOWN SCREW. 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, NORK, S., JONES, C., HARDING, S., MIRZA, S., AND ROUTT, JR., M.L. (2001). PERCUTANEOUS STABILIZATION OF U-SHAPED SACRAL FRACTURES USING ILIOSACRAL SCREWS: TECHNIQUE AND EARLY RESULTS. JOURNAL OF ORTHOPAEDIC TRAUMA, 15 (4), 238-246. THE AUTHORS CONDUCTED A RETROSPECTIVE CLINICAL STUDY TO PRESENT THE TECHNIQUE AND EARLY RESULTS OF PERCUTANEOUS STABILIZATION OF U-SHAPED SACRAL FRACTURES WITH ATTENTION TO NEUROLOGIC RECOVERY AND MAINTENANCE OF FRACTURE REDUCTION OF THE SACRUM. DURING A 38 MONTH PERIOD, 13 PATIENTS (11 MEN, TWO WOMEN, MEAN AGE 39 YEARS) WERE TREATED WITH PERCUTANEOUS ILIOSACRAL SCREW STABILIZATION FOR CLOSED, DISPLACED U-SHAPED SACRAL FRACTURES. TWENTY-FIVE FLUOROSCOPICALLY GUIDED SYNTHES 7.0-MILLIMETER CANNULATED CANCELLOUS ILIOSACRAL SCREWS WERE USED; ELEVEN PATIENTS HAD BILATERAL SCREW FIXATIONS; ONE PATIENT HAD UNILATERAL DOUBLE SCREW FIXATION; AND ONE PATIENT HAD UNILATERAL SINGLE SCREW FIXATION. CLINICAL FOLLOW-UP AVERAGED 14 MONTHS. ALL FRACTURES HEALED CLINICALLY AND RADIOGRAPHICALLY. ONE PATIENT WITH POOR COMPLIANCE BECAUSE OF A PSYCHIATRIC CONDITION HAD INCOMPLETE ILIOSACRAL SCREW DISENGAGEMENT OCCUR WITHOUT FIXATION FAILURE. SHE WAS THE ONLY PATIENT TREATED WITH A SINGLE UNILATERAL SCREW. THIS SCREW CHANGE CAUSED BUTTOCK PAIN AND WAS REMOVED 12 WEEKS AFTER INJURY DURING A GENERAL ANESTHETIC FOR ANOTHER SURGICAL PROCEDURE. THE AUTHORS CONCLUDED THAT PERCUTANEOUS FIXATION DIMINISHES POTENTIAL BLOOD LOSS AND OPERATIVE TIMES AS COMPARED WITH OPEN TECHNIQUES. THIS REPORT IS FOR AN UNKNOWN CANCELLOUS SCREW. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260620 SCREW, FIXATION, BONE HWC SYNTHES(USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention