BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCPTL INV-Y PLATE ASSY, 37MM

    MDR report key: 7393580 · Received April 3, 2018

    Report

    Report Number
    1526439-2018-50300
    Event Type
    Malfunction
    Date Received
    April 3, 2018
    Date of Event
    March 7, 2018
    Report Date
    March 7, 2018
    Manufacturer
    DEPUY SPINE INC
    Product Code
    KWP
    UDI-DI
    (01)UNKNOWN
    PMA / PMN Number
    K002733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. 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 IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). VISUAL EXAMINATION AT THE MACROSCOPIC LEVEL REVEALS THAT THE FRACTURE WAS LOCATED AT THE WEB FEATURE ON THE WASHER COMPONENT. THE MISSING SEGMENT OF THE WASHER COMPONENT WAS NOT RETURNED FOR ANALYSIS. DEVICE WAS THEN SENT FOR FRACTURE ANALYSIS. THE FRACTURE ANALYSIS REPORT REVEALS AN OVERALL GRAINY ROUGH REGION WHICH IS INDICATIVE OF A FATIGUE FAILURE. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING. A DEFINITIVE ROOT CAUSE FOR THE WEB FEATURE ON THE WASHER COMPONENT OF THE OCCIPITAL PLATE FRACTURING CANNOT BE POSITIVELY DETERMINED. HOWEVER, THE FRACTURE ANALYSIS REPORT REVEALS AN OVERALL GRAINY ROUGH REGION WHICH IS INDICATIVE OF A FATIGUE FAILURE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS WERE FOUND, THIS COMPLAINT FILE 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.

    Description of Event or Problem · 1

    DURING THE PROCEDURE IS BROKEN THE SCREW FOR WASHER ON THE SUMMIT OCCIPITAL PLATE PRODUCT CODE 174661037 (SUMMIT) LOT NOT REPORTED Q-TY-1. EVENT DAY - (B)(6) 2018, 10-00 A.M. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237638 OCPTL INV-Y PLATE ASSY, 37MM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP DEPUY SPINE INC WA1104 (01)UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1