BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE,FIXATION,SPINAL INTERLAMINAL

    MDR report key: 5113655 · Received September 30, 2015

    Report

    Report Number
    2520274-2015-16103
    Event Type
    Injury
    Date Received
    September 30, 2015
    Report Date
    September 17, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    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. LA DEFINO, H., SCARPARO,P., (2005) FRACTURES OF THORACOLUMBAR SPINE: MONOSEGMENTAL FIXATION. INJURY, INT. J. CARE INJURED (2005) 36, S-B90¿S-B97. THIS REPORT IS FOR UNKNOWN USS SYSTEM /UNKNOWN QUANTITY/UNKNOWN LOT. ADDITIONAL PRODUCT CODES: MNI, MNH, KWP AND KWQ. (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. 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

    LITERATURE ARTICLE RECEIVED: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: LA DEFINO, H., SCARPARO,P., (2005) FRACTURES OF THORACOLUMBAR SPINE: MONOSEGMENTAL FIXATION. INJURY, INT. J. CARE INJURED (2005) 36, S-B90 - S-B97. BRASIL. THE PURPOSE OF THE STUDY WAS TO FOLLOW 18 PATIENTS WITH FRACTURES OF THE THORACOLUMBAR SPINE UNDERGOING THE SURGICAL TREATMENT OF POSTERIOR MONOSEGMENTAL FIXATION AND ARTHRODESIS. PATIENT FOLLOW-UP RANGED FROM 2-12 YEARS (MEAN: 6.65 +/- 2.96), AND THE PATIENTS WERE ASSESSED BY CLINICAL EVALUATION, RADIOGRAPHIC STUDY, AND FUNCTIONAL EVALUATION. THERE WERE 18 PATIENTS 17 MALE AND 1 FEMALE. THE AGE RANGE WAS FROM 22 - 55 WITH A MEAN AGE OF 35.36. THE CAUSES OF THE FRACTURES WERE MOTOR VEHICLE ACCIDENTS IN 17 PATIENTS AND FALL FROM A HEIGHT IN ONE PATIENT. THE LESION WAS LOCALIZED IN T10-T11 IN TWO PATIENTS (11.1%), T11-T12 IN FOUR PATIENTS(22.2%), T12-L1 IN SIX PATIENTS (33.3%), L1-L2 IN TWO PATIENTS (11.1%), L2-L3 IN ONE PATIENT (5.5%),AND IN L3-L4 IN THREE PATIENTS (16,6%). THE SURGERY PERFORMED WAS POSTERIOR MONOSEGMENTAL FIXATION AND ARTHRODESIS. THE IMPLANTS USED WERE USS SYSTEM (SYNTHES). REPORTED COMPLICATIONS AT FOLLOW UP WERE PAIN( 6 - NO PAIN, 9 - OCCASIONAL PAIN, 1 - MODERATE PAIN, 1- MODERATE TO INTENSE PAIN) AND 1 CASE OF DISABILITY DEFINED AS UNABLE TO RETURN TO WORK. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN USS SYSTEM RELATED TO PAIN AND DISABILITY. THIS REPORT IS FOR 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646015 APPLIANCE,FIXATION,SPINAL INTERLAMINAL NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention