BEUDAMED
    FDA Adverse Event Injury Summary report: N

    USS-II NUT TAN GREEN

    MDR report key: 6657989 · Received June 21, 2017

    Report

    Report Number
    1000562954-2017-10105
    Event Type
    Injury
    Date Received
    June 21, 2017
    Report Date
    June 7, 2017
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    NKB
    UDI-DI
    07611819728011
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE CODES: MNI, MNH, KWP, KWQ. EXPLANT DATE IS UNKNOWN. (B)(6). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER 9929422. MANUFACTURING LOCATION: (B)(4). DATE OF MANUFACTURE: 21. APRIL 2016. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE COMPLAINED IMPLANT HAS BEEN FORWARDED TO THE RESPONSIBLE MANUFACTURING SIDE FOR AN INVESTIGATION. WE ARE NOW IN THE RECEIPT OF THE INVESTIGATION RESULT. THE PART REFERRED ON THE MANUFACTURING INVESTIGATION (ART. 04.607.402/ LOT. 9910497 "USS -II-POLYAXIAL HEAD") HAS BEEN RETURNED ASSEMBLED WITH THE PART REFERRED ON THE MANUFACTURING INVESTIGATION (ART. 04.607.412/ LOT. L065774 "USS - II-POLYAXIAL SLEEVE") AND WITH ANOTHER ITEM (ART. 499.294/ LOT. 9929422 "USS-II NUT") WHICH IS NOT PART OF THESE MANUFACTURING INVESTIGATIONS BUT IT HAS BEEN EVALUATED TOO BECAUSE IT'S INVOLVED IN THE LOCKING MECHANISM WITH THE ROD DESCRIBED IN THE COMPLAINT CONDITION. A SCREW, WHICH IS NOT PARTS OF THESE MANUFACTURING INVESTIGATIONS, HAS ALSO BEEN RETURNED BUT IT HAS NOT BEEN EVALUATED BECAUSE NOT INVOLVED IN THE COMPLAINT CONDITION. THE PARTS RETURNED AND THE NUT WERE RE-INSPECTED FOR ALL THE FEATURES PERTINENT TO THE COMPLAINT CONDITION ACCORDING TO THE PRODUCT INVESTIGATION MATRIX "LOOSE". ALL THE FEATURES RELATED TO LOCKING MECHANISM OF THE ROD INSIDE THE ASSEMBLED POLYAXIAL HEAD COUPLED WITH THE SLEEVE AND THE NUT WERE VERIFIED AND RESULTED CONFORMING; THE CLAMPING RING COMPONENT OF THE POLYAXIAL HEAD COULD NOT BE MEASURED BECAUSE BLOCKED ON THE BODY COMPONENT DUE TO THE POST PRODUCTION DAMAGES. THE FUNCTIONALITY OF THE CLAMPING RING COMPONENT INSIDE THE POLYAXIAL HEAD WAS MEASURED IN PROCESS WHEN IT WAS ASSEMBLED AND VERIFIED ACCORDING THE WORK INSTRUCTION AND NO NONCONFORMANCE HAVE BEEN REPORTED. FROM THE VISUAL INSPECTION IT HAS BEEN NOTED THAT THE NUT WAS NOT CORRECTLY SCREWED INSIDE THE BODY COMPONENT AND BOTH THE NUT AND THE BODY COMPONENT THREADS WERE FOUND VISUALLY DAMAGED POST PRODUCTION DUE TO A PROBABLE INCORRECT ALIGNMENT BETWEEN THE TWO ITEMS. THE INCORRECT ALIGNMENT COULD HAVE COMPROMISED THE PERFORMANCE OF THE LOCKING MECHANISM. NO VISUAL DEFECTS MANUFACTURING RELATED HAVE BEEN IDENTIFIED. CONSIDERING THAT ALL RELEVANT MEASURABLE PRODUCT FEATURES MEET SPECIFICATION AND NO VISUAL DEFECTS MANUFACTURING RELATED HAVE BEEN IDENTIFIED ON RETURNED ITEMS, THE CONCLUSION OF THE PRODUCT INVESTIGATION IS THAT PARTS REFERRED IN THE MANUFACTURING INVESTIGATIONS AND THE NUT ARE CONFORMING FROM A MANUFACTURING PERSPECTIVE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A UNIVERSAL SPINE SYSTEM (USS II) POLYAXIAL 3D-HEAD, A USS II POLYAXIAL SLEEVE, AND USS-II NUT TAN GREEN FOR RODS LOOSENED POSTOPERATIVELY. INITIALLY THE IMPLANTS WERE IMPLANTED ON (B)(6) 2017 AND A REVISION TOOK PLACE ON (B)(6) 2017. THE PATIENT STATUS IS GOOD. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437456 USS-II NUT TAN GREEN ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES MEZZOVICO 9929422 07611819728011

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention