BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI CERVICAL SPINE LOCKING PL VARIABLE ANGLE 3 LEVEL/48MM

    MDR report key: 5996157 · Received October 4, 2016

    Report

    Report Number
    2520274-2016-14783
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 15, 2016
    Report Date
    September 15, 2016
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    KWQ
    PMA / PMN Number
    K031276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE RETURNED TO MANUFACTURER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON PART # 450.172, LOT # 8991917: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 23.MAY.2014. NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A MANUFACTURING INVESTIGATION WAS PERFORMED. PLATE RECEIVED IN A BAG FOR STERILIZATION. THE DATA ETCHED ON THE PLATE MATCH WITH THE DATA REPORTED IN THE COMPLAINT. ONE BUSHING IS MISSING FROM ONE HOLE. ACCORDING TO THE INSPECTION SHEET AFTER ASSEMBLING THE BUSHING POSITION IS 100% VERIFIED THROUGH VISUAL INSPECTION AND THE MOVEMENT OF THE BUSHING INSIDE THE HOLE IS 100% VERIFIED WITH A GAGE. NO NON-CONFORMANCE HAS BEEN DOCUMENTED IN THE DHR. THE RETURNED PLATE WAS VISUALLY INSPECTED: ONE BUSHING IS MISSING; ALL OF THE OTHER BUSHINGS ARE PRESENT IN THE HOLES, NO VISUAL DEFECTS MANUFACTURING RELATED WERE NOTICED. THE FEATURES PERTINENT WITH THE COMPLAINT CONDITION WERE MEASURED. THE HOLE WHERE THE BUSHING IS MISSING WAS FULLY MEASURED AND ALL THE FEATURES RESULTED CONFORMING TO SPECIFICATIONS. SINCE THE BUSHING IS MISSING THE CONFORMITY OF THE PLATE CANNOT BE DETERMINED. THE COMPLAINT IS CONFIRMED SINCE THE BUSHING IS MISSING BUT THE COMPLAINT IS NOT VALID SINCE NO EVIDENCE MANUFACTURING RELATED FOUND. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. 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

    PATIENT DATE OF BIRTH AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. (B)(4). DEVICE WAS NOT IMPLANTED/EXPLANTED. EVENT OCCURRED DURING THE PROCEDURE, NEW PLATE WAS INSERTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. DEVICE 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY ON (B)(6) 2016. DURING THE SURGERY, AFTER ALL FOUR (4) SCREWS WERE IMPLANTED INTO POSITION; THE SURGEON REALIZED THAT THE RING WAS OUTSIDE OF THE PLATE. THE RING WAS REMOVED WITHOUT PROBLEMS OR ADDITIONAL INTERVENTION. PLATE HAD NOT BEEN BENDED BEFORE. THE INITIAL PLATE WAS RETRIEVED AND A NEW PLATE WAS INSERTED. SURGERY WAS PROLONGED BY 20 MINUTES. THIS REPORT IS FOR ONE (1) TI CERVICAL SPINE LOCKING PL VARIABLE ANGLE 3 LEVEL/48MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648018 TI CERVICAL SPINE LOCKING PL VARIABLE ANGLE 3 LEVEL/48MM APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ SYNTHES MEZZOVICO 8991917

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR