BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIF RETRACTOR SYSTEM

    MDR report key: 19326061 · Received May 15, 2024

    Report

    Report Number
    3012120772-2024-00022
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    March 18, 2024
    Report Date
    June 24, 2024
    Manufacturer
    TEDAN SURGICAL INNOVATIONS, INC
    Product Code
    FWZ
    UDI-DI
    00843059100945
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED QTY:1, P/N: AL-0103, LOT:1222 AND QTY:5, P/N: AL-0103, LOT:0423. THE AL-0103 RING CLAMPS ARE CURRENTLY BEING EVALUATED. THE INVESTIGATION IS ONGOING. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED AT THIS TIME. NO FURTHER DETAILS WERE PROVIDED BY THE REPORTER. THE CASE WAS COMPLETED AFTER THE PROPER RETRACTION WAS ACHIEVED. NO PATIENT INJURY WAS REPORTED. POTENTIAL ADVERSE EFFECTS: INJURY, TRAUMA, INFECTION AND DELAYED PROCEDURE.

    Additional Manufacturer Narrative · 0

    THE AL-0103 RING CLAMPS WERE EVALUATED AND THE RESULTS OF THE EVALUATION ARE AS FOLLOW: · THE EVALUATED AL-0103 RING CLAMPS (QTY:1, P/N: AL-0103, LOT:1222) & (QTY:5, P/N: AL-0103, LOT:0423) WERE RECEIVED IN A SEIZED CONDITION. THE CLAMPS HAD MINIMAL MOVEMENT AND WERE HEAVILY DAMAGED DUE TO THE REMOVING TOOLS. · THE CLAMPS WERE ABLE TO BE SET FREE(UNSEIZE) AND FUNCTIONALITY WAS RESTORED WITH THE APPLICATION OF LUBRICANT. HOWEVER, DAMAGED WAS NOTED ON THE THREADS. · A LACK OF LUBRICATION WAS NOTED AS A ROOT CAUSE. NO FURTHER DETAILS WERE PROVIDED BY THE REPORTER. THE CASE WAS COMPLETED AFTER THE PROPER RETRACTION WAS ACHIEVED. NO PATIENT INJURY WAS REPORTED. POTENTIAL ADVERSE EFFECTS: INJURY, TRAUMA, INFECTION AND DELAYED PROCEDURE.

    Description of Event or Problem · 0

    ON 18 MARCH 2024, SEASPINE WAS MADE AWARE OF AN INTRA-OPERATIVE MALFUNCTION INVOLVING THE ALIF RETRACTOR SYSTEM. THE CASE OCCURRED ON (B)(6) 2024. IT WAS REPORTED THAT SEVERAL AL-0103 RING CLAMPS FROZE MID-CASE WHICH MADE CHANGING THE BLADES DIFFICULT. THIS MALFUNCTION CAUSED A SURGICAL DELAY OF APPROXIMATELY 45-60 MINUTES. THE CASE WAS COMPLETED AFTER THE PROPER RETRACTION WAS ACHIEVED. NO PATIENT INJURY WAS REPORTED. ON 17 APRIL 2024 THE AL-0103 RING CLAMPS WERE RECEIVED FOR EVALUATION. THE RETURNED PARTS ARE AS FOLLOW: (QTY:1, P/N: AL-0103, LOT:1222) & (QTY:5, P/N: AL-0103, LOT:0423). THIS REPORT IS 4 OUT OF 5 FOR LOT 0423. THIS EVENT WAS ORIGINALLY REPORTED UNDER 3012120772-2024-00009. THIS REPORT WAS FILED TO DOCUMENT THE DIFFERENT LOT NUMBERS RECEIVED.

    Description of Event or Problem · 0

    ON 18 MARCH 2024, SEASPINE WAS MADE AWARE OF AN INTRA-OPERATIVE MALFUNCTION INVOLVING THE ALIF RETRACTOR SYSTEM. THE CASE OCCURRED ON (B)(6) 2024. IT WAS REPORTED THAT SEVERAL AL-0103 RING CLAMPS FROZE MID-CASE WHICH MADE CHANGING THE BLADES DIFFICULT. THIS MALFUNCTION CAUSED A SURGICAL DELAY OF APPROXIMATELY 45-60 MINUTES. THE CASE WAS COMPLETED AFTER THE PROPER RETRACTION WAS ACHIEVED. NO PATIENT INJURY WAS REPORTED. ON 17 APRIL 2024 THE AL-0103 RING CLAMPS WERE RECEIVED FOR EVALUATION. THE RETURNED PARTS ARE AS FOLLOW: (QTY:1, P/N: AL-0103, LOT:1222) & (QTY:5, P/N: AL-0103, LOT:0423). THIS REPORT IS 4 OUT OF 5 FOR LOT 0423. THIS EVENT WAS ORIGINALLY REPORTED UNDER 3012120772-2024-00009. THIS REPORT WAS FILED TO DOCUMENT THE DIFFERENT LOT NUMBERS RECEIVED. ON 30 MAY 2024 THE EVALUATION WAS COMPLETED AND AS A RESULT THIS SUPPLEMENTAL REPORT WAS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440998 ALIF RETRACTOR SYSTEM RING CLAMP FWZ TEDAN SURGICAL INNOVATIONS, INC AL-0103 0423 00843059100945

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other