BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI POLYAXIAL HEAD FOR USS POLYAXIAL

    MDR report key: 6538940 · Received May 2, 2017

    Report

    Report Number
    1000562954-2017-10052
    Event Type
    Injury
    Date Received
    May 2, 2017
    Report Date
    April 6, 2017
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    NKB
    UDI-DI
    10705034736655
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEVICE LOOSENING IS NOT KNOWN. ADDITIONAL DEVICE CODES: MNI, MNH, KWP, KWQ. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO 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. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 05. APRIL 2016. 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. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (TI POLYAXIAL HEAD FOR USS POLYAXIAL, PART NUMBER 04.607.402, LOT NUMBER 9910497). THE SUBJECT DEVICE WAS RETURNED TO THE MANUFACTURER WITH THE COMPLAINT CONDITION STATING: PART NUMBER 04.607.402 (TI POLYAXIAL HEAD FOR USS POLYAXIAL), PART NUMBER 04.607.412 (TI COLLAR FOR 6.0MM RODS FOR USS POLYAXIAL), AND THE NUT WERE RE-INSPECTED FOR ALL THE FEATURES PERTINENT TO THIS COMPLAINT CONDITION ACCORDING TO THE PRODUCT INVESTIGATION MATRIX ¿LOOSE¿. ALTHOUGH THE NUT IS PART OF THE MANUFACTURING INVESTIGATIONS BUT WAS EVALUATED BECAUSE IT WAS INVOLVED IN THE LOCKING MECHANISM WITH THE ROD AS DESCRIBED IN THE COMPLAINT CONDITION. 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 KLEMMING COMPONENT OF THE POLYAXIAL HEAD COULD NOT BE MEASURED BECAUSE BLOCKED ON THE KORPER COMPONENT DUE TO THE POST PRODUCTION DAMAGES. THE FUNCTIONALITY OF THE KLEMMING COMPONENT INSIDE THE POLYAXIAL HEAD WAS MEASURED IN PROCESS WHEN IT WAS ASSEMBLED AND VERIFIED ACCORDING TO WORK INSTRUCTION AND NO NONCONFORMANCES HAVE BEEN REPORTED. FROM THE VISUAL INSPECTION IT HAS BEEN NOTED THAT THE NUT WAS NOT CORRECTLY SCREWED INSIDE THE KOERPER COMPONENT AND BOTH THE NUT AND KOERPER 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. THE CONCLUSION OF THE PRODUCT INVESTIGATION IS THE PARTS REFERRED IN THIS INVESTIGATION AND ARE ALL CONFORMING FROM A MANUFACTURING PERSPECTIVE. THE DISPOSITION IS CONFIRMED SINCE THERE WAS INCORRECT ALIGNMENT AND COULD HAVE COMPROMISED THE LOCKING MECHANISM; HOWEVER, THE ISSUE IS NOT MANUFACTURING RELATED SINCE THE COMPLAINED PARTS ARE CONFORMING FROM A MANUFACTURING PERSPECTIVE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED. 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

    THE COMPLAINED IMPLANT HAS BEEN FORWARDED TO THE RESPONSIBLE MANUFACTURING SIDE FOR A INVESTIGATION. WE ARE NOW IN THE RECEIPT OF THE INVESTIGATION RESULT. THE PART (04.607.402/ LOT. 9910497 "USS -II-POLYAXIAL HEAD") HAS BEEN RETURNED ASSEMBLED WITH THE PART (04.607.412/ LOT. L065774 "USS - II-POLYAXIAL SLEEVE") AND WITH ANOTHER ITEM (499.294/ LOT. 9929422 "USS-II NUT") WHICH IS NOT PART OF THIS EVALUATION BUT IT HAS BEEN EVALUATED TOO BECAUSE IT'S INVOLVED IN THE LOCKING MECHANISM WITH THE ROD DESCRIBED IN THE COMPLAINT CONDITION. A SCREW 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" REPORTED IN THE PROCEDURE. 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 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. DCRM REVIEW, EVENT IS ADEQUATELY COVERED. 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 IS REPORTED PATIENT WAS IMPLANTED WITH THE UNIVERSAL SPINE SYSTEM (USS) II AT UNKNOWN LEVELS ON (B)(6) 2017. X-RAY TAKEN ON (B)(6) 2017 REVEALED THAT THE POLYAXIAL 3D HEAD AND THE COLLAR HAD BECOME LOOSE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 FOR REVISION. IT IS NOT KNOWN WHAT WAS IMPLANTED DURING THE REVISION PROCEDURE. CONCOMITANT DEVICES REPORTED: TITANIUM NUT (PART 499.294, QUANTITY 1). THIS REPORT IS FOR ONE (1) USS POLYAXIAL 3D HEAD. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319169 TI POLYAXIAL HEAD FOR USS POLYAXIAL ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES MEZZOVICO 9910497 10705034736655

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention