BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5203857 · Received November 5, 2015

    Report

    Report Number
    2520274-2015-17034
    Event Type
    Injury
    Date Received
    November 5, 2015
    Report Date
    October 14, 2015
    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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THIS REPORT IS FOR UNKNOWN CORTEX SCREW, UNKNOWN QUANTITY, UNKNOWN LOT. UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. VERTEBRAL ARTERY INJURY, INCOMPLETE REDUCTION. 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: MADAWI, A.A., ET AL. (1997) RADIOLOGICAL AND ANATOMICAL EVALUATION OF THE ATLANTOAXIAL TRANSARTICULAR SCREW FIXATION TECHNIQUE. J. NEUROSURG, VOLUME 86: 961-968. BETWEEN FEBRUARY 1991 AND MARCH 1995, 58 ADULTS AND THREE CHILDREN UNDERWENT OPERATION VIA THE ATLANTOAXIAL TRANSARTICULAR SCREW FIXATION TECHNIQUE FOR A VARIETY OF INDICATIONS. THE PATIENTS RANGED IN AGE FROM 7 TO 77 YEARS (MEAN 48.3 +- 17.1 YEARS). EIGHTEEN PATIENTS WERE MALE AND 43 WERE FEMALE; FOLLOW-UP PERIODS RANGED FROM 6 TO 72 MONTHS (MEAN 26 +- 12.2 MONTHS). A 3.5MM AO CORTICAL SCREW (SYNTHES; (B)(4)) WAS USED ORIGINALLY, WHEREAS LAG SCREWS ARE NOW AVAILABLE. THE INDICATIONS FOR SCREW FIXATION WERE CLASSIFIED INTO THREE GROUPS: GROUP I: 37 PATIENTS WITH RHEUMATOID ARTHRITIS, SEVEN OF WHOM HAD A HISTORY OF SIGNIFICANT NECK TRAUMA, AND FIVE IN WHOM POSTERIOR C1-2 FUSION HAD FAILED. GROUP II: CONSISTED OF 15 PATIENTS WITH TRAUMATIC ATLANTOAXIAL INSTABILITY, INCLUDING TWO CHILDREN WITH ATLANTOAXIAL ROTATORY SUBLUXATION. GROUP III: COMPOSED OF NINE PATIENTS WITH MISCELLANEOUS INDICATIONS, INCLUDING THREE WITH CHIARI MALFORMATIONS ASSOCIATED WITH ANTEROPOSTERIOR DECOMPRESSION, AND ONE EACH WITH PSORIATIC ARTHROPATHY, DOWN'S SYNDROME, TUMOR, INFECTION, DEGENERATIVE INSTABILITY, AND C1-2 APOPHYSEAL ARTHRITIS. COMPLICATIONS INCLUDED THE FOLLOWING: 3 PATIENTS WHO EXPERIENCED INTRAOPERATIVE VERTEBRAL ARTERY (VA) LACERATION DUE TO LOW POSITIONED SCREWS. TWO PATIENTS WHO EXPERIENCED SCREW BREAKAGE AND PAIN AND REQUIRED REVISION SURGERY. THREE PATIENTS WHO HAD BROKEN SCREWS ASSOCIATED WITH INCOMPLETE REDUCTION. THIS IS REPORT #3 OF #3 FOR (B)(4). THIS REPORT IS FOR UNKNOWN 3.5MM AO CORTICAL SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733967 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention