BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, PEDICLE SPINAL FIXATION, FOR DDD

    MDR report key: 5066932 · Received September 10, 2015

    Report

    Report Number
    2520274-2015-15713
    Event Type
    Injury
    Date Received
    September 10, 2015
    Report Date
    August 27, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    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 ET AL (APRIL 2011) SAGITTAL DECOMPENSATION AFTER CORRECTIVE OSTEOTOMY FOR LUMBAR DEGENERATIVE KYPHOSIS. SPINE VOLUME 36, NUMBER 8, PP E538¿E544. THIS REPORT IS FOR UNKNOWN ROD, USS 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE; LEE ET AL (2011) SAGITTAL DECOMPENSATION AFTER CORRECTIVE OSTEOTOMY FOR LUMBAR DEGENERATIVE KYPHOSIS. SPINE VOLUME 36, NUMBER 8, PP E538-E544. THE OBJECTIVE OF THIS RETROSPECTIVE STUDY WAS TO CLASSIFY THE TYPES AND IDENTIFY RELATED FACTORS ON SAGITTAL DECOMPENSATION AFTER CORRECTIVE OSTEOTOMY FOR LUMBAR DEGENERATIVE KYPHOSIS (LDK). THE STUDY WAS DESIGNED WITH 23 CASES (AVG AGE: 63.6 YEARS, 23 FEMALES) AND THE MEAN FOLLOW-UP PERIOD WAS 45.7 MONTHS. RADIOGRAPHIC PARAMETERS ANALYZED INCLUDED SAGITTAL BALANCE, THE CROSSSECTIONAL AREA OF PARA-VERTEBRAL MUSCLES. THE TYPE OF SAGITTAL DECOMPENSATION WAS CLASSIFIED INTO THORACIC (GROUP T) AND LUMBAR DECOMPENSATION (GROUP L) WITH A REFERENCE LINE FROM THE POSTEROSUPERIOR CORNER OF THE SACRUM TO THE CENTER OF THE T12-L1 DISC. THE MEAN NUMBER OF FUSION SEGMENTS WAS 7.7. SAGITTAL BALANCE IMPROVED FROM 26.4 CM TO 4 CM IMMEDIATELY AFTER OPERATION BUT DETERIORATED TO 11.2 CM AT THE LAST FOLLOW-UP. THE DECOMPENSATION WAS GREATER IN GROUP T (11 CASES) THAN IN GROUP L (12 CASES). THE COMPARATIVE ANALYSIS SHOWED SIGNIFICANT DIFFERENCES BETWEEN GROUPS T AND L IN THORACIC KYPHOSIS AT THE LAST FOLLOW-UP PREOPERATIVE THORACIC KYPHOTIC ANGLE, MEAN RATIO OF CROSS-SECTIONAL AREA OF PARAVERTEBRAL MUSCLES TO INTERVERTEBRAL DISC IN T12-L1, AND INCIDENCE OF THE PREOPERATIVE COMPENSATORY THORACIC LORDOSIS. THERE WAS NEITHER INFECTION NOR MAJOR COMPLICATIONS. THIS REPORT REFERS TO ONE FEMALE PATIENT WITH PSEUDARTHROSIS OF PEDICLE SUBTRACTION OSTEOTOMY (PSO) WITH ROD BREAKAGE THAT REQUIRED PSEUDARTHROSIS REPAIR AND ROD CHANGE. THIS IS REPORT 5 OF 5 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN ROD, USS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598004 ORTHOSIS, PEDICLE SPINAL FIXATION, FOR DDD NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention