BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3982330 · Received August 5, 2014

    Report

    Report Number
    2520274-2014-12634
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 9, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. KANTELHARDT, S., KERIC, N., & GIESE, A. (2012) MANAGEMENT OF C2 FRACTURES USING ISO-C3D GUIDANCE: A SINGLE INSTITUTION'S EXPERIENCE. ACTA NEUROCHIR 154, 1781-1787. THIS REPORT IS FOR AN UNKNOWN SCREW. (B)(6). 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 JOURNAL ARTICLE: MANAGEMENT OF C2 FRACTURES USING ISO-C3D GUIDANCE: A SINGLE INSTITUTION'S EXPERIENCE. KANTELHARDT, S., KERIC, N., & GIESE, A. (2012) MANAGEMENT OF C2 FRACTURES USING ISO-C3D GUIDANCE: A SINGLE INSTITUTION'S EXPERIENCE. ACTA NEUROCHIR 154, 1781-1787. THIS WAS A RETROSPECTIVE STUDY OF 16 PATIENTS (9 FEMALE, 7 MALE, MEAN AGE 65 YEARS, RANGE 9-89 YEARS) BETWEEN APRIL 2011 AND APRIL 2012 WITH TRAUMATIC FRACTURES INVOLVING C2. DURING THIS PERIOD, ALL C2 FRACTURES WERE TREATED; 6 PATIENTS RECEIVED CANNULATED ANTERIOR LAG-SCREW (SYNTHES) FIXATION OF ODONTOID FRACTURES, 2 UNDERWENT ISOLATED POSTERIOR LAG-SCREW (SYNTHES) FIXATION OF HANGMAN'S FRACTURE, AND 8 PATIENTS WERE IMPLANTED WITH LATERAL MASS OR ISTHMIC SCREWS (THIRD PARTY). ONE PATIENT (IMPLANTED WITH AN ANTERIOR LAG SCREW) EXPERIENCED DYSPHAGIA TWO DAYS AFTER SURGERY; AND REPEAT COMPUTED TOMOGRAPHY (CT) SCAN SHOWED SCREW LOOSENING AND DISLOCATION INTO THE PREVERTEBRAL SOFT TISSUE. SHE WAS REVISED ON DAY FOUR AND UNDERWENT C1 LATERAL MASS AND C2 ISTHMIC SCREW PLACEMENT. ANOTHER PATIENT WITH ODONTOID FRACTURE TYPE II (IMPLANTED WITH AN ANTERIOR LAG SCREW) EXPERIENCED POSTOPERATIVE OCCIPITAL HYPAESTHESIA CORRESPONDING TO THE LEFT C1 DERMATOMA. NON-SURGICAL COMPLICATIONS INCLUDED ONE INTRAOPERATIVE NON ST-ELEVATION CARDIAC INFARCTION; FIVE DAYS LATER, THIS WAS FOLLOWED BY A FATAL MAJOR INFARCTION (UNSPECIFIED IMPLANT). THERE WAS ALSO DEVELOPMENT OF A CHRONIC SUBDURAL HEMATOMA (UNSPECIFIED IMPLANT) IN ONE PATIENT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456807 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention