BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5216455 · Received November 11, 2015

    Report

    Report Number
    2520274-2015-17119
    Event Type
    Malfunction
    Date Received
    November 11, 2015
    Date of Event
    April 14, 2015
    Report Date
    October 25, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THIS REPORT IS FOR AN UNKNOWN 7.0 MM FULLY THREADED CANNULATED 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 NARRATIVE: 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: SULLIVAN, M., SCOLARO, J., MILBY, A. AND MEHTA, S. (2015). ISOLATED PELVIC RING INJURIES: FUNCTIONAL OUTCOMES FOLLOWING PERCUTANEOUS, POSTERIOR FIXATION. EUR J ORTHO SURG TRAUMATOL 25:1025-1030. THE OBJECTIVE OF THIS STUDY WAS TO CHARACTERIZE PELVIC-SPECIFIC FUNCTIONAL OUTCOMES IN PATIENTS WITH PARTIALLY UNSTABLE PELVIC RING INJURIES TREATED WITH POSTERIOR ONLY PERCUTANEOUS SCREW FIXATION OF THE PELVIC RING. BETWEEN (B)(6) 2007 AND (B)(6) 2011, 16 SUBJECTS (13 FEMALES AND 3 MALES) WITH A MEAN AGE OF 42.4 YEARS (RANGE 18-90 YEARS). THE MEAN AGE FOR FEMALE PATIENTS WAS 44.8 YEARS AND 32 YEARS FOR MALE PATIENTS. ELEVEN INJURIES WERE UNILATERAL AND FIVE WERE BILATERAL. THERE WAS ONE REPORT OF A SCREW THAT BREACHED THE ANTERIOR CORTEX OF THE UPPER SACRAL SEGMENT. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN 7.0 MM FULLY THREADED CANNULATED SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747235 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1