BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE SCREW MUST MC SCREW Ø6X45

    MDR report key: 16023335 · Received December 21, 2022

    Report

    Report Number
    3005180920-2022-00979
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    December 6, 2022
    Report Date
    December 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    PMA / PMN Number
    K210427
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20-DEC-2022: LOT 2122516: (B)(4). EXPIRATION DATE: 2026-09-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 20-DEC-2022: PEDICLE SCREW 03.58.445 MUST MC SCREW Ø6X45 (K210427) LOT 2122516: (B)(4). EXPIRATION DATE: 2026-09-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: IN A LUMBO-SACRAL STABILIZATION OF A RATHER HEAVY MAN OF 63 WITH SIGNIFICANT SPONDILOSIS AND STENOSIS, THE TWO SACRAL SCREWS ARE FOUND BROKEN AT 3 MONTHS, ALTHOUG THE CLINICAL EVOLUTION IS FAVOURABLE. A CANNULATED 6.0MM SCREW IS OF COURSE CHALLENGED BY A HEAVY MAN WHOSE LORDOSIS IS DRASTICALLY CHANGED; THERE WERE PROBABLY MEDICAL/ANATOMICAL REASONS THAT MADE THE CHOICE OF A LARGER SCREW NOT APPLICABLE. NO INCONVENIENCE IS TO BE EXPECTED FROM THE FRACTURE OF THE SCREWS EXCEPT THE IMPOSSIBILITY TO RETRIEVE THEM SHOULD THIS BE DESIRED BY THE SURGEON. WE HAVE NO REASON TO SUSPECT A FAULTY DEVICE AT THE ORIGIN OF THIS COMPLAINT.

    Description of Event or Problem · 0

    ON THE (B)(6) 2022, THE PATIENT UNDERWENT A PRIMARY CBT PLIF L4-S1 WITH THE IMPLANTATION OF A SINGLE TITANIUM INTERBODY CAGE AT EACH LEVEL. THE PATIENT HAD GOOD BONE QUALITY. ON THE (B)(6) 2022, THE PATIENT CAME IN FOR THE 3-MONTH POST-OP FOLLOW-UP AND X-RAYS REVEALED A BILATERAL FRACTURE OF THE TWO 6.0MM CANNULATED PEDICLE SCREWS AT S1. NO TRAUMA AND STRENUOUS ACTIVITIES IN THE POST-OPERATIVE PERIOD WERE REPORTED BY THE SURGEON OR PATIENT. LUMBOSACRAL LORDOSIS WENT FROM 4 DEGREES PRE-OP TO 11 DEGREES POST-OP. THERE IS NO PLAN TO REVISE THE SCREWS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024786 PEDICLE SCREW MUST MC SCREW Ø6X45 SPINE PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 03.58.445 2122516

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other