BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM TI ROD 120MM

    MDR report key: 9162859 · Received October 7, 2019

    Report

    Report Number
    2939274-2019-61256
    Event Type
    Malfunction
    Date Received
    October 7, 2019
    Report Date
    September 18, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    NKG
    UDI-DI
    10705034788968
    PMA / PMN Number
    K142838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO NONCONFORMANCE'S OR ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE 3.5MM TI ROD 120MM (P/N 498.125 LOT 6882258) WAS RECEIVED BY US CQ AND IT WAS OBSERVED THAT THE DISTAL PORTION ON THE ROD WAS BROKEN. IT IS CLEARLY SHEARED OFF AND THUS, THE COMPLAINT CONDITION IS CONFIRMED. THE ROD WAS BENT AS WELL. DEVICE FAILURE/ DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: THE OUTER 3.5 + 0 /- 0.016 MM OF THE ROD GOT MEASURED. OUTER DIAMETER: D = 3.5 +0 /- 0.016, CALIPER: CA 215P, MEASURED ROD DIAMETER = 3.50 MM. CONCLUSION: THE MEASURING RESULT DOES SHOW CONFORMITY. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THIS DEVICE. DOCUMENT/ SPECIFICATION REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: A DEFINITIVE ASSIGNABLE ROOT CAUSE FOR THE POST MANUFACTURING DAMAGE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED BECAUSE OF THIS EVALUATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    IT WAS REPORTED THAT ON (B)(6) 2019, THE 3.5MM TITANIUM ROD WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 3.5MM TI ROD 120MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957208 3.5MM TI ROD 120MM ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION NKG WRIGHTS LANE SYNTHES USA PRODUCTS LLC 498.125 6882258 10705034788968

    Patients

    Seq Age Sex Outcome Treatment
    1