BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE,FIXATION,SPINAL INTERLAMINAL

    MDR report key: 6518445 · Received April 25, 2017

    Report

    Report Number
    2520274-2017-11495
    Event Type
    Injury
    Date Received
    April 25, 2017
    Report Date
    April 6, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    HORN, E., AND ET AL. (2006) ATLANTOAXIAL STABILIZATION WITH THE USE OF C1¿3 LATERAL MASS SCREW FIXATION. J NEUROSURG SPINE 5: 172¿177. THIS REPORT IS FOR UNKNOWN ¿SPINE (AXON SYSTEM)/UNKNOWN QUANTITY/UNKNOWN LOT. 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.

    Additional Manufacturer Narrative · 1

    DATE ON (B)(4) WAS INCORRECTLY REPORTED AS APR 6, 2017. THE CORRECT DATE IS MAY 10, 2017. 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 HORN, E., AND ET AL. (2006) ATLANTOAXIAL STABILIZATION WITH THE USE OF C1¿3 LATERAL MASS SCREW FIXATION. J NEUROSURG SPINE 5: 172¿177. THE PURPOSE OF THIS ARTICLE IS TO REVIEW RETROSPECTIVE CASES IN WHICH A NOVEL TECHNIQUE OF FIXATING THE ATLANTOAXIAL COMPLEX BY USING C1¿3 LATERAL MASS SCREW FIXATION IN CONJUNCTION WITH C-2 SUBLAMINAR WIRES. THE STUDY WAS PERFORMED BETWEEN JUNE 2001 AND MAY 2005. THE STUDY INCLUDED 10 PATIENTS, WHICH CONSISTED OF SIX (6) MEN AND FOUR (4) WOMEN, WITH A MEDIUM AGE OF 62.6 YEARS (RANGE 23-84 YEARS). THE AVERAGE FOLLOW-UP DURATION WAS 13.1 MONTHS (RANGE 4-27 MONTHS). A COPY OF THE LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN ¿SPINE (AXON SYSTEM) AND REFERS TO ONE (1) PATIENT (FEMALE, (B)(6)) HAD MILD PAIN AT THE GRAFT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302013 APPLIANCE,FIXATION,SPINAL INTERLAMINAL KWP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention