BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI CSLP VARIABLE ANGLE 4 LEVEL/80MM

    MDR report key: 12215015 · Received July 22, 2021

    Report

    Report Number
    2939274-2021-04239
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    June 25, 2021
    Report Date
    June 25, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KWQ
    UDI-DI
    10705034781051
    PMA / PMN Number
    K031276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H4, H6: PART # 450.186, SYNTHES LOT # 4212229, SUPPLIER LOT # NA, RELEASE TO WAREHOUSE DATE: 22 JAN 2001, MANUFACTURED BY SYNTHES BRANDYWINE, NO NCR'S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE TI CSLP VARIABLE ANGLE 4 LEVEL/80MM (P/N: 450.186, LOT #: 4212229) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DEVICE WAS MISSING THE BUSHING (ES0120) COMPONENT IN ONE OF THE HOLES. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. DIMENSIONAL INSPECTION: THERE WAS CONCLUSIVE EVIDENCE THAT THE RETURNED DEVICE WAS MISSING COMPONENT, SO THE DIMENSIONAL INSPECTION WAS NOT PERFORMED. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED . TI CERVICAL SPINE LOCKING PLATE VARIABLE ANGLE, 4 LEVEL: CURRENT) AND MANUFACTURED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED FOR THE TI CSLP VARIABLE ANGLE 4 LEVEL/80MM (P/N: 450.186, LOT #: 4212229). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE COMPONENT WAS LIKELY MISPLACED DURING THE DEVICE'S HANDLING. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    PRODUCT COMPLAINT # (B)(4). PATENT IDENTIFIER: (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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) 2021, PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE FOR SPINAL FUSION. CSLP VA PLATE LOCKING RING CAME DISLODGED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 30 MINUTES. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES (2) DEVICES. THIS REPORT IS FOR (1) TI CSLP VARIABLE ANGLE 4 LEVEL/80MM. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108859 TI CSLP VARIABLE ANGLE 4 LEVEL/80MM APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 450.186 4212229 10705034781051

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR TI CSLP VARIABLE ANGLE 4 LEVEL/80MM| TI CSLP VARIABLE ANGLE 4 LEVEL/80MM