MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. PEDICLE SCREW SYSTEM; MUST LT 15MM SHORT - PEDICLE SCREW Ø7X45 CANN

Model Number	03.57.035
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 march 2025.(b)(4) items manufactured and released on 08-nov-2022.Expiration date: 2027-10-12.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.
Event or Problem Description
Primary surgery was performed at th10-l3 due to osteoporotic vertebral compression fracture.Pedicle screw breakage observed at left side of l2 during removal surgery.
Additional Manufacturer Narrative
Visual inspection performed by r&d department: issue: the inlay of the screw is found to be out of position.Background: must lt screws are assembled through a punching process that deforms the tulip, thereby retaining the inlay and the screw.This batch was manually punched, with the punching area visually inspected and the operation performed on both sides.Analysis: a possible root cause of the inlay displacement could be the application of excessive compressive force during surgery, which may have led to the disassembly of the inlay.It is not possible to determine whether the disassembly occurred during the primary surgery or the revision procedure.If the inlay had been disassembled during the primary surgery, but the rod and setscrew had already been properly fixed, the disassembly of the inlay would not have represented a critical issue, as the construct would have remained intact and stable.Root cause: inspection of the part confirmed that the manufacturing process was carried out according to specifications.It might be that unique excessive forces were during the surgery, but this cannot be confirmed and a certain root cause cannot be defined.
Event or Problem Description
Primary surgery was performed at th10-l3 due to osteoporotic vertebral compression fracture.During removal of the pedicle screw at left side of l2, the inlay was found disassembled.

• Brand Name: M.U.S.T. PEDICLE SCREW SYSTEM
• Common Device Name: MUST LT 15MM SHORT - PEDICLE SCREW Ø7X45 CANN
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 21760521
• Report Number: 3005180920-2025-00280
• Device Sequence Number: 21024424
• Product Code: NKB
• UDI-Device Identifier: 07630971278462
• UDI-Public: 07630971278462
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 03.57.035
• Device Lot Number: 2227772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian