BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM MESH

    MDR report key: 4021408 · Received August 19, 2014

    Report

    Report Number
    1526439-2014-11786
    Event Type
    Injury
    Date Received
    August 19, 2014
    Report Date
    July 28, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TITANIUM MESH WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE TITANIUM MESH COULD NOT BE CONDUCTED AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. A 12-MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE PRODUCT FAMILY FOUND NO RELATED COMPLAINTS. WITHOUT THE RETURN OF THE DEVICE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. NO CORRECTIVE ACTION/PREVENTIVE ACTION IS NECESSARY AT THIS TIME AS WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NOT RETURNED.

    Description of Event or Problem · 1

    MEDICAL SAFETY REPORTED COMPLAINT FROM LITERATURE THAT WAS REVIEWED FOR POST MARKET SURVEILLANCE. ARTICLE TITLE: POSTERIOR VERTEBRAL COLUMN RESECTION IN EARLY ONSET SPINAL DEFORMITIES (JESZENSZKY, D.) PUBLICATION DATE: AUG 2013. THE PURPOSE OF THIS STUDY WAS TO ILLUSTRATE THE AUTHORS EXPERIENCE WITH POSTERIOR VERTEBRAL COLUMN RESECTION (PVCR), WITH SPINAL FUSION LIMITED TO THE RESECTION SITE, IN A SERIES OF FOUR PATIENTS WITH SEVERE EOSD. THE AUTHORS DESCRIBE THE SURGICAL TECHNIQUE, ESPECIALLY IN RELATION TO THE UNIQUE ANATOMICAL FEATURES OF YOUNG CHILDREN, AND PRESENT DATA ON THE EXTENT OF DEFORMITY CORRECTION AND THE RATE AND TYPE OF COMPLICATIONS. N=1: LOSS OF CORRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499814 TITANIUM MESH SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention