BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4217403 · Received October 31, 2014

    Report

    Report Number
    2520274-2014-13885
    Event Type
    Injury
    Date Received
    October 31, 2014
    Report Date
    September 23, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UEHARA, M., ET AL COMPUTER-ASSISTED C1-C2 TRANSARTICULAR SCREW FIXATION "MAGERL TECHNIQUE" FOR ATLANTOAXIAL INSTABILITY ASIAN JOURNAL SPINE(2012) 6:168-177. THIS REPORT IS FOR 1 UNKNOWN 3.0MM CANNULATED SCREW. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WERE PROVIDED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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: COMPUTER-ASSISTED C1-C2 TRANSARTICULAR SCREW FIXATION ¿MAGERL TECHNIQUE¿ FOR ATLANTOAXIAL INSTABILITY. UEHARA, M. AND ET AL. (2012) ASIAN SPINE 6: 168-177. THIS WAS A RETROSPECTIVE STUDY OF PATIENTS WHO UNDERWENT ATLANTOAXIAL FUSION BY MAGERL¿S PROCEDURE UNDER THE CT-BASED NAVIGATION SYSTEM FROM OCTOBER 1998 TO JANUARY 2011. IMPLANTS USED FOR THE PROCEDURE WERE TRANS BONE SCREW (COMPETITOR'S DEVICE) IN 5 CASES, UNIVERSAL CANNULATED SCREW SET (COMPETITOR'S DEVICE) IN 14 CASES. IN ONE CASE INVOLVING A 5 YEAR OLD GIRL, 3.0 MM CANNULATED SCREWS (SYNTHES INC., (B)(4)) WERE USED AS IMPLANTS. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE SURGICAL RESULTS DURING FOLLOW-UP OF THE COMPUTER¿ASSISTED C1 ¿ C2 TRANSARTICULAR SCREW FIXATION FOR ATLANTOAXIAL INSTABILITY AND THE USEFULNESS OF THE NAVIGATION SYSTEM. TWENTY PATIENTS (8 MEN AND 12 WOMEN; MEAN AGE 57.9 ± 15.4 YEARS) WHO HAD THREE MONTHS OR MORE OF FOLLOW-UP WERE INCLUDED IN THE STUDY. A FRAMELESS STEREOTACTIC IMAGE-GUIDED SYSTEM WAS USED IN SCREW PLACEMENT AND FIXATION OF THE ATLANTOAXIAL JOINTS. A TOTAL OF 38 SCREWS WERE INSERTED FOR THE OPERATED PATIENTS. THE CONDITION OF THE VERTEBRAL ARTERY WAS EVALUATED PREOPERATIVELY BY MAGNETIC RESONANCE ANGIOGRAPHY. SURGICAL TIME AND BLOOD LOSS WERE EVALUATED. RADIOGRAPHIC MEASUREMENTS EVALUATED BEFORE SURGERY AND AT THE FINAL FOLLOW-UP PERIOD INCLUDE ATLANTO-DENS INTERVAL (ADI), SPACE AVAILABLE FOR THE CORD (SAC), AND THE RANAWAT VALUE. CLINICAL SYMPTOMS EVALUATED BEFORE SURGERY AND AT THE FINAL FOLLOW-UP PERIOD INCLUDE THE JAPANESE ORTHOPAEDIC ASSOCIATION (JOA) SCORE AND THE RANAWAT PAIN SCORE. POSTOPERATIVE SCREW POSITION WAS EVALUATED BY CT SCAN. BONY UNION AND OCCURRENCE OF POSTOPERATIVE SUBAXIAL SUBLUXATION WERE ALSO EVALUATED. THE MEAN OBSERVATION PERIOD WAS 33 MONTHS. THE MEAN SURGICAL TIME WAS 205 MINUTES WITH AN AVERAGE BLOOD LOSS VOLUME OF 242 MLS. SEVEN OUT OF 20 PATIENTS UNDERWENT ADDITIONAL LAMINOPLASTY OR LAMINECTOMY. EVALUATION OF THE RADIOGRAPHS MEASUREMENTS SHOWED THAT AT THE FINAL FOLLOW-UP, ATLANTOAXIAL SUBLUXINATION WAS CORRECTED AND ALL THE AVERAGE ADIS AND SAC HAD IMPROVED. EVALUATION OF PATIENT COMPLAINTS SHOWED THAT BOTH THE JAO SCORE AND RANAWAT PAIN SCORE HAD IMPROVED POSTOPERATIVELY COMPARED TO THOSE BEFORE SURGERY. OCCIPITAL AND/OR CERVICAL PAIN THAT PRESENTED BEFORE SURGERY WAS DIMINISHED OR RESOLVED IN ALL PATIENTS. THE SCREW PERFORATION RATE WAS 2.6% (1/38). ONE (B)(6) GIRL, WHO WAS CASE #13, HAD A SCREW THAT CAUSED LATERAL PERFORATION BUT THE SCREW WAS PENETRATED TO THE ATLANTOAXIAL JOINTS. NO NEWLY DEVELOPED NEUROLOGICAL DEFICITS OCCURRED DURING SURGERY. NEITHER SPINAL CORD INJURIES NOR SPINAL NERVE ROOT INJURIES WERE OBSERVED POSTOPERATIVELY. NO VENTRAL ARTERY INJURY WAS ENCOUNTERED. ALL PATIENTS WHO WERE FOLLOWED-UP DURING ONE YEAR OR MORE AFTER SURGERY ACHIEVED BONY FUSION. THIS STUDY DEMONSTRATED THAT THE CT-BASED NAVIGATION SYSTEM IS AN EFFECTIVE SUPPORT DEVICE FOR MAGERL'S PROCEDURE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SCREW AND REFERS TO THE SERIOUS INJURY OF LATERAL PERFORATION SECONDARY TO SCREW MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699641 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention