MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. PEDICLE SCREW SYSTEM; MUST LT 15MM SHORT - PEDICLE SCREW Ø6X35 CANN

Model Number	03.57.023
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
When reviewing the post-operative images on the same day of the surgery, bone fracture in l2 and l3 was discovered.Compared to the intraoperative trajectory on nextar screen, the screws were inserted more laterally, while the screws appeared to be inserted with the correct trajectory during the surgery.It is unknown if a revision/additional surgery is planned.
Additional Manufacturer Narrative
Considering the available information no futher analysis can be performed.Waiting more info from the branch to perform this event investigation.
Event or Problem Description
When reviewing the post-operative images on the same day of the surgery, bone fracture in l2 and l3 was discovered.Compared to the intraoperative trajectory on nextar screen, the screws were inserted more laterally, while the screws appeared to be inserted with the correct trajectory during the surgery.No revision/additional surgery was performed or planned.
Additional Manufacturer Narrative
R&d analysis.Based on the review of intraoperative screenshots and post-operative ct images, screws were implanted from l2 to s2ai.One screw at the l2 level was found to be significantly lateral, which most likely caused the fracture of the l2 transverse process.The screw position at l3 appears acceptable, and no clear evidence of bone damage at that level was identified on the available images.The intraoperative nextar screenshots shared shows correct screw trajectories of the first part of the surgery.However, the presence of a second intraoperative scan suggests that a change or movement of the clamp may have occurred during the procedure.The sequence of events between the first and second scans could not be reconstructed due to the lack of additional information.Based on the available data, no system malfunction or navigation inaccuracy can be confirmed.The deviation in screw placement at l2 is most likely related to an intraoperative change of the reference system (clamp movement) that occurred after the placement of the first screws.Due to incomplete information, a definitive conclusion cannot be reached.Conclusion: based on the information available, no evidence of system malfunction or navigation error was identified.The observed deviation in screw placement is most likely associated with an intraoperative alteration of the reference system, such as a clamp displacement, occurring after the insertion of the initial screws.Due to the lack of complete procedural details, the root cause cannot be definitively established.Correction and additional information: b5, h6 (annex b), h11.

• Brand Name: M.U.S.T. PEDICLE SCREW SYSTEM
• Common Device Name: MUST LT 15MM SHORT - PEDICLE SCREW Ø6X35 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: 23669516
• Report Number: 3005180920-2025-01160
• Device Sequence Number: 21302694
• Product Code: NKB
• UDI-Device Identifier: 07630971278370
• UDI-Public: 07630971278370
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K203482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/27/2026

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: 03.57.023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian