BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETSCREW

    MDR report key: 17796598 · Received September 22, 2023

    Report

    Report Number
    3007728266-2023-00005
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    August 4, 2023
    Report Date
    September 22, 2023
    Product Code
    NKB
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    9 SETSCREWS, REFERENCE TLF-SC 00 00-S, ARE INVOLVED: BATCH NUMBER 6-3812 X 3 UNITS : SUBCONTRACTOR: ALPES CN. MANUFACTURING DATE: 26.NOV.2021. 20 PARTS OF THE SAME LOT HAVE BEEN MANUFACTURED. 0 NC HAS BEEN DETECTED DURING THE MANUFACTURING STEPS. 8 PARTS OF THE LOT HAVE BEEN IMPLANTED. 0 CPT HAS BEEN RECEIVED. BATCH NUMBER 5-8607 X 1 UNIT: SUBCONTRACTOR: AFT. MANUFACTURING DATE: 21.DEC.2021. 502 PARTS OF THE SAME LOT HAVE BEEN MANUFACTURED. 0 NC HAS BEEN DETECTED DURING THE MANUFACTURING STEPS. 377 OF THE LOT HAVE BEEN IMPLANTED. 0 CPT HAS BEEN RECEIVED. BATCH NUMBER 5-8601 X 1 UNIT: SUBCONTRACTOR: AFT. MANUFACTURING DATE: 18.MAY.2021. 1050 PARTS OF THE SAME LOT HAVE BEEN MANUFACTURED. 0 NC HAS BEEN DETECTED DURING THE MANUFACTURING STEPS. 891 OF THE LOT HAVE BEEN IMPLANTED. 0 CPT HAS BEEN RECEIVED. BATCH NUMBER 5-7167 X 1 UNIT: SUBCONTRACTOR: ALPES CN. MANUFACTURING DATE: 25.MAR.2021. 100 PARTS OF THE SAME LOT HAVE BEEN MANUFACTURED. 0 NC HAS BEEN DETECTED DURING THE MANUFACTURING STEPS. 50 OF THE LOT HAVE BEEN IMPLANTED. 0 CPT HAS BEEN RECEIVED. BATCH NUMBER 6-4127 X 2 UNITS: SUBCONTRACTOR: ALPES CN. MANUFACTURING DATE: 29.NOV.2021. 150 PARTS OF THE SAME LOT HAVE BEEN MANUFACTURED. 0 NC HAS BEEN DETECTED DURING THE MANUFACTURING STEPS. 50 OF THE LOT HAVE BEEN IMPLANTED. 0 CPT HAS BEEN RECEIVED. BATCH NUMBER 5-8599 X 1 UNIT: SUBCONTRACTOR: AFT. MANUFACTURING DATE: 13.APR.2021. 794 PARTS OF THE SAME LOT HAVE BEEN MANUFACTURED. 0 NC HAS BEEN DETECTED DURING THE MANUFACTURING STEPS. 668 OF THE LOT HAVE BEEN IMPLANTED. 0 CPT HAS BEEN RECEIVED. ALL THE MANUFACTURING FOLDERS HAVE BEEN CHECKED. NO NON-CONFORMITY WAS REVEALED. RAW MATERIAL AND DIMENSIONAL CONTROL ARE CONFORMING TO THE SPECIFICATIONS. WE RECEIVED THE 9 SETSCREWS. THEY HAVE BEEN ANALYZED BY THE R&D TEAM, THEY CONFIRMED THAT THEY HAVE BEEN SCREWED AND NO ISSUE HAS BEEN DETECTED ON THE DEVICES. OUR REP. ON THE FIELD CANNOT CONFIRM THE FINAL TIGHTENER THAT HAS BEEN USED DURING THE SURGERY (SEE EMAIL ON 13.SEP.2023). BASED ON THE ABOVE INFORMATION WE CANNOT NEITHER EXPLAIN THE EVENT, NOR IDENTIFY ANY CLEAR ROOT CAUSE. SINCE THE LAUNCH OF THE PRODUCT, 82566 SETSCREWS OF THIS RANGE HAVE BEEN IMPLANTED AND THIS IS THE FOURTH CASE REPORTING THIS KIND OF ISSUE, WHICH REPRESENTS 0,005% OF ISSUE. THE RATE IS VERY LOW. WE CLOSE THE CASE AS IS.

    Description of Event or Problem · 0

    THE CUSTOMER COMPLAINT FORM REPORTS THAT: "ON A T10 TO S2, THE PATIENT HAD SETSCREWS POP OFF AT S1 AND S2 AND LOOSE SET SCREWS AT L3 TO L5. ORIGINAL SURGERY (B)(6) 2023". THE EVENT WAS DETECTED DURING A FOLLOW-UP VISIT, THE SURGEON REVISED WITH NEW SETSCREWS ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113213 SETSCREW SETSCREW NKB TLF-SC 00 00-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown