BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 5433426 · Received February 12, 2016

    Report

    Report Number
    2520274-2016-10984
    Event Type
    Injury
    Date Received
    February 12, 2016
    Report Date
    February 9, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LEE S.C., CHEN J.F., LEE S.T. (2004) MANAGEMENT OF ACUTE ODONTOID FRACTURES WITH SINGLE ANTERIOR SCREW FIXATION. JOURNAL OF CLINICAL NEUROSCIENCE (2004) 11(8), 890¿895 TAIWAN. THIS REPORT IS FOR UNKNOWN AO LAG SCREW/UNKNOWN QUANTITY/UNKNOWN LOT. (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (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

    LITERATURE ARTICLE RECEIVED : THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: LEE S.C., CHEN J.F., LEE S.T. (2004) MANAGEMENT OF ACUTE ODONTOID FRACTURES WITH SINGLE ANTERIOR SCREW FIXATION. JOURNAL OF CLINICAL NEUROSCIENCE (2004) 11(8), 890-895 TAIWAN. PURPOSE OF STUDY: THE USE OF ANTERIOR ODONTOID SCREW FIXATION HAS GROWN IN POPULARITY FOR THE MANAGEMENT OF ACUTE, UNSTABLE ANDERSON AND D-ALONZO TYPE II AND ROSTRAL TYPE III ODONTOID FRACTURES. THIS STUDY CRITICALLY REVIEWS OUR CLINICAL EXPERIENCE OF 48 PATIENTS WITH SINGLE ODONTOID SCREW FIXATION FOR THE TREATMENT OF TYPE II AND TYPE III ODONTOID FRACTURES BETWEEN 1997 AND 2001. PATIENT DEMOGRAPHIC: PATIENTS RANGED IN AGE FROM 16 TO 78 YEARS (MEAN 37.2 YEARS). THERE WERE 37 MALES AND 11 FEMALES. THIRTY-NINE PATIENTS HAD TYPE II ODONTOID FRACTURES, WHILE NINE PATIENTS HAD ROSTRAL TYPE III. PRE-OPERATIVELY, ONE PATIENT PRESENTED NOT BREATHING WITH COMPLETE QUADRIPLEGIA AND FOUR PRESENTED WITH INCOMPLETE QUADRIPARESIS. ONE PATIENT WAS UNCONSCIOUS DUE TO AN ASSOCIATED HEAD INJURY. ALL OTHER PATIENTS WERE NEUROLOGICALLY INTACT BUT COMPLAINED OF NECK PAIN AND LIMITED MOTION. TYPE OF SURGERY: THE STANDARD PROCEDURE USED IN THIS STUDY INVOLVED A RIGHT TRANSVERSE ANTEROMEDIAL INCISION AT APPROXIMATELY THE LEVEL OF THE C5-6 DISC SPACE, WITH A SUBSEQUENT ROUTINE ANTEROMEDIAL APPROACH TO THE VERTEBRAL COLUMN TO EXPOSE THE ANTEROINFERIOR MARGIN OF C2. ONE 2.4-MM KIRCHNER'S WIRE, UNDER OPEN-MOUTH AP AND LATERAL FLUOROSCOPIC CONTROL, WAS THEN INSERTED FROM THE ANTERIOR ASPECT OF THE INFERIOR MARGIN OF C2, THROUGH THE CENTRAL AXIS OF THE DENS, TO THE OPPOSING APICAL CORTICAL BONE. THE KIRCHNER'S WIRE WAS THEN REPLACED BY AN ADEQUATE LENGTH AO 3.5 MM SELF-TAPPING PARTIALLY THREADED LAG SCREW. IMPLANTS USED: AO 3.5 MM SELF-TAPPING PARTIALLY THREADED LAG SCREW. COMPLICATIONS REPORTED: SCREW MALPOSITION OCCURRED IN THREE CASES WITH REVISION SURGERY IN EACH CASE AND NONUNION WAS REPORTED IN 4% OF CASES. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN LAG SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90991 SCREW,FIXATION,BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention