MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. PEDICLE SCREW SYSTEM; MUST LT 15MM LONG - PEDICLE SCREW Ø6X45 CANN

Model Number	03.59.025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 july 2025.Must lt 03.59.025 must lt 15mm long - pedicle screw ø6x45 cann lot 2323299: (b)(4) items manufactured and released on 23-may-2023.Expiration date: 26-april-2028.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional components involved: batch review performed on 07 july 2025 must lt 03.59.025 must lt 15mm long - pedicle screw ø6x45 cann (k203482) lot 2324236 x2 : (b)(4) items manufactured and released on 29-aug-2023.Expiration date: 14-aug-2028.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review (2 devices involved in this complaint).Batch review performed on 07 july 2025 must lt 03.59.035 must lt 15mm long - pedicle screw ø7x45 cann (k203482) lot 2326318 x2 : (b)(4) items manufactured and released on 21-sept-2023.Expiration date: 28-aug-2028.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review (2 devices involved in this complaint).Conclusions: based on the information available no definitive root cause can be established, while 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.
Event or Problem Description
At about 1 year and 2 months from the primary surgery, the patient came in reporting back pain.Surgeon removed two right-side screws and added bone graft.Surgery was completed successfully.

• Brand Name: M.U.S.T. PEDICLE SCREW SYSTEM
• Common Device Name: MUST LT 15MM LONG - PEDICLE SCREW Ø6X45 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: 22518024
• Report Number: 3005180920-2025-00681
• Device Sequence Number: 9231873
• Product Code: KWQ
• UDI-Device Identifier: 07630971279162
• UDI-Public: 07630971279162
• 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
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

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 Expiration Date: 05/23/2023
• Device Model Number: 03.59.025
• Device Lot Number: 2323299
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2023
• 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: Unknown