BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOSIS, SPINAL PEDICLE

    MDR report key: 6030733 · Received October 14, 2016

    Report

    Report Number
    2520274-2016-14910
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    August 26, 2016
    Report Date
    October 4, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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: KOKABU, T., ET AL. (2016) EFFECTS OF MULTILEVEL FACETECTOMY AND SCREW DENSITY ON POSTOPERATIVE CHANGES IN SPINAL ROD CONTOUR IN THORACIC ADOLESCENT IDIOPATHIC SCOLIOSIS SURGERY. PLOS ONE 11(8): E0161906. DOI:10.1371/JOURNAL.PONE.0161906. THE STUDY WAS AN INVESTIGATOR-INITIATED OBSERVATIONAL COHORT STUDY CONDUCTED AT A SINGLE MEDICAL CENTER AND APPROVED BY INSTITUTIONAL REVIEW BOARD. DATA FROM 49 PATIENTS (1 MALE, 48 FEMALE) WITH LENKE TYPE 1 OR TYPE 2 AIS CURVES WHO UNDERWENT POSTERIOR THORACIC CURVE CORRECTION BETWEEN JUNE 2009 AND APRIL 2016 WERE EVALUATED. SIX-MILLIMETER DIAMETER TITANIUM-ALLOY IMPLANT RODS AND POLYAXIAL PSS (USS II POLYAXIAL, DEPUY SYNTHES, (B)(4)) WERE USED TO CORRECT THE SCOLIOSIS DEFORMITY. ALL RODS WERE PREBENT ONLY AT A SINGLE PLANE. THERE WAS A SIGNIFICANT RELATIONSHIP BETWEEN POSTOPERATIVE THORACIC KYPHOSIS (TK) AND THE POSTOPERATIVE IMPLANT ROD ANGLE OF CURVATURE. THE ROD AT THE CONCAVE SIDE WAS SIGNIFICANTLY DEFORMED AFTER THE SURGICAL TREATMENT. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN RODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682304 ORTHOSIS, SPINAL PEDICLE NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention