BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4277120 · Received November 25, 2014

    Report

    Report Number
    2520274-2014-14725
    Event Type
    Injury
    Date Received
    November 25, 2014
    Report Date
    November 4, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AGE AT THE TIME OF SURGERY: (B)(6) (ILIAC GROUPS) AND (B)(6) (CONTROL GROUP) (B)(4). 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: FRANZIN ET AL (2014). RADIOGRAPHIC AND FUNCTIONAL EVALUATION OF THE ILIAC BONE GRAFT IN THE TREATMENT OF ADOLESCENT IDIOPATHIC SCOLIOSIS. JOURNAL OF PEDIATRIC ORTHOPAEDICS B, 23: 307¿311. THIS STUDY AIMED TO ASSESS THE IMPACT OF THE USE OF AN ADDITIONAL ILIAC BONE GRAFT ON FUNCTIONAL AND RADIOGRAPHIC RESULTS AFTER THORACIC SPINE ARTHRODESIS WITH PEDICLE SCREWS IN PATIENTS WITH ADOLESCENT IDIOPATHIC SCOLIOSIS (AIS). PARTICIPANTS WERE DIVIDED INTO TWO GROUPS: A CONTROL GROUP (CG) THAT RECEIVED ONLY LOCAL BONE (N =19) AND A SECOND GROUP THAT, IN ADDITION TO THIS PROCEDURE, RECEIVED AN ILIAC GRAFT(IG) (N= 22). THE GROUPS WERE HOMOGENEOUS IN TERMS OF SEX, AGE AT THE TIME OF SURGERY, FOLLOW-UP TIME, AND PEDICLE SCREWS DENSITY. THE TWO GROUPS WERE HOMOGENEOUS WITH RESPECT TO THE NUMBER OF PEDICLE SCREWS USED IN THE CONSTRUCTS. ALL PATIENTS WERE OPERATED ON BY THE SAME SURGICAL TEAM USING THE SAME TYPE OF TITANIUM IMPLANT. IN ALL CASES, MONOAXIAL SCREWS, 6MM LONGITUDINAL RODS, AND TWO TRANSVERSE LOCKING DEVICES WERE USED. PATIENTS WERE SUBJECTED TO A FOLLOW-UP EVALUATION AFTER A MINIMUM PERIOD OF ONE YEAR. FUSION WAS EVALUATED IN THE POSTOPERATIVE RADIOGRAPHS. PSEUDOARTHROSIS WAS CONSIDERED AS A VALUE OF MORE THAN 10 DEGREE IN THE OPERATED CURVE COMPARED WITH THE FIRST POSTOPERATIVE FOLLOW-UP VISIT. WHEN BREAKAGE OF IMPLANTS OR IMPLANT LOOSENING WAS OBSERVED, PSEUDOARTHROSIS WAS ALSO REGISTERED. FUSION RATE AND PSEUDOARTHROSIS RATE WERE RECORDED FOR EACH GROUP. MEDICAL CHARTS WERE REVIEWED FOR INFORMATION ON INTRAOPERATIVE COMPLICATIONS RELATED TO ILIAC BONE GRAFTING, SUCH AS ARTERIAL OR NERVOUS LESIONS, ILIAC FRACTURE, OR SACROILIAC JOINT LESION. THE OCCURRENCE OF INFECTION WAS ALSO REGISTERED. THERE WERE NO RECORDS OF INTRAOPERATIVE COMPLICATIONS IN GRAFT REMOVAL, SUCH AS NERVOUS OR ARTERIAL INJURY, PELVIC FRACTURE, OR INJURY OF THE SACROILIAC JOINT. NONE OF THE PATIENTS DEVELOPED INFECTION IN THE DONOR SITE GRAFT, REQUIRING SURGICAL DEBRIDEMENT OR ANTIBIOTIC THERAPY. IN ONLY ONE CASE, IN THE IG GROUP, BREAKAGE OF A PEDICLE SCREW WAS REGISTERED (IN L1, THE MOST INFERIOR INSTRUMENTED VERTEBRA) 12 MONTHS AFTER SURGERY. THE CASE WAS REGISTERED AS AN EVENT OF PSEUDOARTHROSIS, BUT THERE WAS NO NEED FOR REOPERATION AS THE PATIENT WAS ASYMPTOMATIC. NO OTHER CASE OF PSEUDOARTHROSIS WAS REGISTERED IN THE PERIOD, AND THE CONSOLIDATION RATE, THEREFORE, WAS 95.4% IN ILIAC GRAFT GROUP AND 100% IN THE CONTROL GROUP. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN USS PEDICLE SCREW, UNKNOWN PART#/LOT#.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764598 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention