BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4200616 · Received October 24, 2014

    Report

    Report Number
    2520274-2014-14029
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    October 6, 2012
    Report Date
    October 1, 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. KIM, J-W ET AL (2012). PERCUTANEOUS ILIOSACRAL SCREWING IN PELVIC RING INJURY USING THREE-DIMENSIONAL FLUOROSCOPY. JOURNAL ORTHOPAEDIC SCIENCE, 18, 87-92. THIS REPORT IS FOR 7 UNKOWN 7.0MM CANNULATED SCREWS. 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: KIM, J-W ET AL (2012). PERCUTANEOUS ILIOSCARAL SCREWING IN PELVIC RING INJURY USING THREE-DIMENSIONAL FLUOROSCOPY. JOURNAL ORTHOPAEDIC SCIENCE, 18, 87-92. ILIOSACRAL SCREW FIXATION IS A POPULAR TECHNIQUE FOR TREATMENT OF UNSTABLE PELVIC INJURIES INVOLVING THE POSTERIOR RING. HOWEVER, SCREW MALPOSITION MAY RESULT IN DANGEROUS COMPLICATIONS INVOLVING INJURY TO ADJACENT NEUROVASCULAR STRUCTURES. THIS STUDY WAS CONDUCTED IN ORDER TO EVALUATE THE RESULTS AND EFFICACY OF USING THREE-DIMENSIONAL FLUOROSCOPY IN THE PERFORMANCE OF ILIOSACRAL SCREW FIXATION. FROM JANUARY TO DECEMBER 2010, TWENTY-NINE PATIENTS (31 CASES, TWO BILATERAL), 17 MEN AND 12 WOMEN WHO SUFFERED INJURY TO THE PELVIC RING REQUIRING SURGICAL TREATMENT WERE INCLUDED IN THIS STUDY. ACCORDING TO THE ASSOCIATION FOR OSTEOSYNTHESIS-ORTHOPAEDIC TRAUMA ASSOCIATION (AO-OTA) CLASSIFICATION, THERE WERE 14 PATIENTS WITH TYPE B, 13 PATIENTS WITH TYPE C, AND 2 PATIENTS WITH A BILATERAL SACRAL FRACTURE. THE MEAN AGE OF PATIENTS WAS 39 YEARS. ONCE THE GUIDE PIN HAD BEEN INSERTED, ITS SAFETY WAS CONFIRMED USING THREE-DIMENSIONAL FLUOROSCOPY; SCREW FIXATION WAS THEN PERFORMED. EIGHTEEN PATIENTS UNDERWENT PERCUTANEOUS ILIOSACRAL SCREW FIXATION AND ANTERIOR FIXATION, WHILE 11 PATENTS UNDERWENT SCREW FIXATION ONLY. POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) WAS PERFORMED FOR EVALUATION OF THE SCREW POSITION, INCLUDING ANY INVASION INTO THE SACRAL FORAMEN OR CANAL AND NEUROVASCULAR INJURY. THE PERFORATION OF THE SCREW WAS DIVIDED ACCORDING TO THE LOCATION (SACRAL ZONES I, II, AND III) AND THE DEGREE (GRADE 0, NO PERFORATION; GRADE 1, PERFORATION \2 MM; GRADE 2, PERFORATION BETWEEN 2 AND 4 MM; GRADE 3, PERFORATION (4 MM). THE MEAN OPERATION TIME WAS 35.6 MIN, AND THE MEAN RADIATION EXPOSURE TIME WAS 85.9 S. FOR ACCURATE LOCATION OF THE GUIDE PIN, ONE PATIENT UNDERWENT THREE-DIMENSIONAL RECONSTRUCTION TWICE. NONE OF THE PATIENTS REQUIRED REOPERATION OR SUFFERED ANY NEUROVASCULAR INJURY. ALTHOUGH SEVEN CASES INVOLVED PERFORATION, ALL WERE LESS THAN 2 MM (GRADE 0: 24 CASES, GRADE 1:7 CASES). THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN 7.0MM CANNULATED SCREW A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678556 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention