BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 40MM THRD LENGTH

    MDR report key: 6593696 · Received May 26, 2017

    Report

    Report Number
    9612488-2017-10234
    Event Type
    Injury
    Date Received
    May 26, 2017
    Report Date
    April 27, 2017
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HWC
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER INSPECTION OF RETURNED DEVICES WAS CONDUCTED. 3 ASSEMBLED SCREW RECEIVED TOGETHER NOT IN THE ORIGINAL PACKAGING. INFORMATION ETCHED ON PRODUCTS MATCH TO COMPLAINT SYSTEM AND PRODUCT INSPECTION: THE RETURNED PARTS WERE RE-INSPECTED FOR ALL THE FEATURES PERTINENT TO THE COMPLAINT CONDITION ACCORDING TO THE PRODUCT INVESTIGATION MATRIX ¿LOOSE¿. ALL THE MEASURABLE FEATURES RELATED TO A POTENTIAL LOOSENING OF THE SCREWS OR BODIES COMPONENT HAVE BEEN REINSPECTED AND FOUND IN SPECIFICATION: FOR THE SCREW LOT#7942649, THE BODY IS NO MORE MEASURABLE BECAUSE VISUALLY DAMAGED POST PRODUCTION (THE BODY IS BLOCKED WITH THE LOCKING CAP AND THE ROD AS CONSEQUENCE OF THE SURGERY). NO VISUAL DEFECTS MANUFACTURING RELATED HAVE BEEN IDENTIFIED BY THE VISUAL INSPECTION. THE RAW MATERIAL HAS BEEN VERIFIED THROUGH REVIEW OF CERTIFICATE DOCUMENTED IN THE DHR REVIEW. NO EVIDENCE OF NONCONFORMANCE MANUFACTURING RELATED FOUND. CONCLUSION: 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 THE RETURNED PARTS ARE CONFORMING FROM A MANUFACTURING PERSPECTIVE. DISPOSITION: MIA IS DISPOSED AS UNCONFIRMED DUE THE FACT THAT THE PRODUCTS WERE RETURNED AND NO MANUFACTURING ISSUES WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW: PART # 499.55, LOT # 8593112: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 27 AUGUST 2013, PART # 499.552, LOT # 8767839, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 12 DECEMBER 2013, PART # 499.551, LOT # 7942649, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 11 JUNE 2012: 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. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. CORRECTED TO PRODUCT MALFUNCTION AND SERIOUS INJURY. THIS REPORT IS FOR ONE (1) UNKNOWN 5.2MM CLICK¿X PEDICLE SCREW WHICH LOOSENED AT S1 LEVEL. LISTED BELOW ARE THE POTENTIAL PART AND LOT NUMBERS FOR THE LOOSENED SCREW; HOWEVER IT IS UNKNOWN OUT OF THESE LISTED SCREWS WHICH SCREW LOOSENED POSTOPERATIVELY: PART # 499.551, LOT # 8593112, QUANTITY 1, PART # 499.551, LOT # 7942649, QUANTITY 1 , PART # 499.552, LOT # 8767839, QUANTITY 1. UDI NUMBER FOR PART # 499.552, LOT # 8767839: (B)(4); UDI NUMBER FOR PART # 499.551, LOT # 8593112: (B)(4); UDI NUMBER FOR PART # 499.551, LOT # 7942649:(B)(4). 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

    DATE OF REPORT: SHOULD BE APRIL 27, 2017 NOT APRIL 28, 2017. 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¿S DATE OF BIRTH , AGE AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. DATE OF POSTOPERATIVE SCREW LOOSENING IS UNKNOWN. ADDITIONAL DEVICE PRODUCT CODES: MNI, MNH, KWP, KWQ (B)(4). IMPLANTED APPROXIMATELY ONE YEAR AGO. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS A VICTIM OF SPINAL CORD INJURY BY FIREARM PROJECTILE IN 2016, WITH L4 FRACTURE REQUIRING L2-L3-L5-S1 ARTHRODESIS. DURING THE INITIAL SURGERY INSUFFICIENCY OF BLOCKERS IN THE SENT BOX WAS VERIFIED (ONLY 7, SURGERY WITH PLACEMENT OF 8 SCREWS, WITHOUT CONTAMINATION OF BLOCKERS DURING THE SURGERY). IT WAS DECIDED TO LEAVE THE L5 SCREW TO THE LEFT WITHOUT A BLOCKER. HOWEVER AT 1 YEAR RETURN THE PATIENT PRESENTED WITH SEVERE LOW BACK PAIN AND SEVERE DEFORMITY IN THE OPERATED AREA. LOOSENING OF THE MATERIAL IN ITS DISTAL PORTION WAS IDENTIFIED BY: - OSTEOLYSIS OF THE FIXING OF THE SCREWS OF S1 AND DISCONNECTION ENTERS THE HEAD AND THE BODY OF THE L5 SCREW TO THE RIGHT. THE HEAD REMAINED ATTACHED TO THE STEM BY THE BLOCKER BUT DISCONNECTED FROM THE BOLT. THE PATIENT UNDERWENT A NEW ARTHRODESIS ON (B)(6) 2017, REPLACING THE L5 SCREWS, REMOVING THE S1 SCREWS AND PLACING ILIAC SCREWS BILATERALLY. THERE WAS, HOWEVER, NO PERMANENT DEFICIT FOR THE PATIENT (WHO WAS ALREADY PARAPLEGIC SINCE THE TIME OF THE ACCIDENT). SURGICAL PROCEDURE WAS WITHOUT COMPLICATIONS. FAVORABLE EVOLUTION; HOSPITAL DISCHARGED THE PATIENT WITHOUT PAIN. PER SURGEON, THE OSTEOLYSIS THAT CAUSED BONE S1 SCREWS TO LOOSEN WAS DUE TO THE OVERLOAD OF THE MATERIAL ON THE SACRAL BONE. THIS OVERLOAD IN TURN WAS DUE TO A FAILURE OF L5 FIXTURE (LEFT BY THE ABSENCE OF BLOCKER AND TO THE RIGHT BY LOOSENING OF THE SCREW HEAD). THIS COMPLAINT ADDRESSES POSTOPERATIVE ISSUES OF S1 LEVEL SCREW LOOSENING AND DISCONNECTION OF RIGHT L5 LEVEL SCREW. THE INTRAOPERATIVE ISSUE OF BLOCKER (LOCKING CAP) MISSING DURING INITIAL SURGERY IS REPORTED UNDER COMPLAINT (B)(4). CONCOMITANT DEVICES REPORTED: 5.2MM TI CLICK'X PEDICLE SCREW PREASSEMBLED 40MM THREAD LENGTH (PART # 499.552, LOT # 8767839, QUANTITY 1), 5.2MM TI CLICK'X PEDICLE SCREW PREASSEMBLED 35MM THREAD LENGTH (PART # 499.551 LOT # 8593112, QUANTITY 1), 5.2MM TI CLICK'X PEDICLE SCREW PREASSEMBLED 35MM THREAD LENGTH (PART # 499.551, LOT # 7942649, QUANTITY 1), 6.0MM TI SOFT ROD 150MM (PART # 498.154, LOT # 8708913, QUANTITY 1), 6.0MM TI SOFT ROD 150MM (PART # 498.154, LOT # 9023296, QUANTITY 1), TI CLICK'X LOCKING CAP FOR TI 3-D HEAD (PART # 498.570, LOT # 8895051, QUANTITY 1), CLICK'X LOCKING CAP FOR TI 3-D HEAD (PART # 498.570, LOT # 9569162, QUANTITY 6) THIS REPORT IS FOR ONE (1) UNKNOWN 5.2MM CLICK¿X PEDICLE SCREW WHICH LOOSENED AT S1 LEVEL.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON PERFORMED A SURGERY APPROXIMATELY ONE YEAR AGO. THE SURGEON USED A CLICK'X PEDICLE SCREW BUT THE IMPLANT BOX MISSED A BLOCKER. AS THE PATIENT WAS ALREADY ANESTHETIZED THE SURGEON DECIDED TO KEEP THE PROCEDURE AND LEFT THE SCREW WITHOUT BLOCKING. DURING THE SURGERY ON (B)(6) 2017 IT WAS NOTED THAT THE SCREW WAS LOOSE. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION AND OUTCOME. THIS REPORT IS FOR ONE (1) 5.2 MM TI CLICK'X® PEDICLE SCREW . THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376505 5.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 40MM THRD LENGTH SCREW, FIXATION, BONE HWC SYNTHES MEZZOVICO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention