BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE SCREW BALINIT TAP CANNULATED - UNDERSIZED - AT- Ø4.5 MM

    MDR report key: 17190246 · Received June 23, 2023

    Report

    Report Number
    3005180920-2023-00459
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    May 25, 2023
    Report Date
    June 23, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05 JUNE 2023: LOT 2055903: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAR-2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: REF. 03.51.10.0616 BALINIT TAP CANNULATED - UNDERSIZED - AT- Ø4.5 MM LOT. 2055903. THE TIP OF THE INSTRUMENT BROKE IN SEVERAL PIECES. CAUSE CAN BE IDENTIFIED IN THE VERY HARD BONE QUALITY. REF. 03.51.10.0594 PROBE - Ø2.7MM FOR MYSPINE LOT. 2250097. PROBE'S TIP IS TWISTED, DUE TO HARD BONE. REF. 03.51.10.0594 PROBE - Ø2.7MM FOR MYSPINE LOT. 2250043. PROBE'S TIP IS BENT, DUE TO HARD BONE. REF. 03.51.10.0238 Ø4.5MM CANNULATED TAPERED TAP UNDERSIZED LOT. 1852517. INNER CANNULATION OF THE TAP IS FILLED WITH BIOLOGICAL MATERIAL. A Ø1.7 K-WIRE CANNOT BE INSERTED FROM BOTH SIDES. IT IS UNKNOWN IF THE CANNULATION WAS STUCK BEFORE THE SURGERY DUE TO SUB OPTIMAL CLEANING. NO DEFECTS OR OTHER WEAR SIGNS CAN BE SEEN ON THE INSTRUMENT. ADDITIONAL PRODUCTS INVOLVED: BATCH REVIEW PERFORMED ON 06 JUNE 2023 ON PEDICLE SCREW 03.51.10.0238 Ø4.5MM CANNULATED TAPERED TAP UNDERSIZED LOT. 1852517. LOT 1852517: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JULY-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 23 JUNE 2023 ON PEDICLE SCREW 03.51.10.0594 PROBE - Ø2.7MM FOR MYSPINE LOT. 2250097. LOT 2250097: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAY-2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 23 JUNE 2023 ON PEDICLE SCREW 03.51.10.0594 PROBE - Ø2.7MM FOR MYSPINE LOT. 2250043. LOT 2250097: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-ARP-2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    DURING MYSPINE CASE 2 LENKE PROBE WAS DEFORMED, ONE CANNULATED TAP BROKE (03.51.10.0616) AND ANOTHER CANULATED TAP (03.51.10.0238) WAS STUCK OF BONE AND NOT USABLE ANYMORE. DELAY OF 1.30H (TOTAL SURGERY TIME 7 HOURS) TO RECOVER THE PARTS OF THE TAP. THE PATIENT HAD VERY HARD BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447802 PEDICLE SCREW BALINIT TAP CANNULATED - UNDERSIZED - AT- Ø4.5 MM SPINE BALINIT TAP CANNULATED LXH MEDACTA INTERNATIONAL SA 2055903

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention