MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM; MUST MC SCREW Ø6X50 CANNULATED

Model Number	03.58.246
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	03/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 months after the primary, the patient came in presenting pain due to two screws that were loose at the l2 level.The surgeon observed that there was poor bone quality.The surgeon removed the two screws and extended the rods in the construct up to the t12 level, but left screws out of the l2 level due to the bone quality.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 18 march 2026.Pedicle screw 03.58.246 must mc screw d 6x50 cannulated (k210427) lot 2327392: (b)(4) items manufactured and released on 19-oct-2023.Expiration date: 2028-09-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Pedicle screw 03.58.246 must mc screw d 6x50 cannulated (k210427) lot 2321445: (b)(4) items manufactured and released on 17-may-2023.Expiration date: 2028-04-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Root cause:based on the information available no definitive root cause can be established, although it is possible to hypothesize that a primary factor of the the loosening was the poor patient bone quality.There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
• Common Device Name: MUST MC SCREW Ø6X50 CANNULATED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 24826099
• Report Number: 3005180920-2026-00274
• Device Sequence Number: 9139928
• Product Code: NKB
• UDI-Device Identifier: 07630971293588
• UDI-Public: 07630971293588
• Combination Product (Y/N): N
• PMA/510(K) Number: K210427
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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: 03.58.246
• Device Lot Number: 2327392
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• 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: Required Intervention
• Patient Sex: Male
• Patient Race: White