MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. RODS; BENT ROD TI 5.5 X 40MM - STERILE

Model Number	03.50.451
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 mar 2026.Pedicle screw 03.50.451 bent rod ti 5.5 x 40mm - sterile (k121115) lot 2323976: (b)(4) items manufactured and released on 21-jun-2023.Expiration date: 2028-jun-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.(2 devices involved in this complaint) pedicle screw 03.52.324 enh.Cann.Pedicle screw 6x45mm + nut (1x) sterile (k141988) lot.2321377: (b)(4) items manufactured and released on 03-may-2023.Expiration date: 2028-apr-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Pedicle screw 03.52.324 enh.Cann.Pedicle screw 6x45mm + nut (1x) sterile (k141988) lot 2322205: (b)(4) items manufactured and released on 12-apr-2023.Expiration date: 2028-mar-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Pedicle screw 03.52.325 enh.Cann.Pedicle screw 6x50mm + nut (1x) sterile (k141988) lot 2323175: (b)(4) items manufactured and released on 17-may-2023.Expiration date: 2028-apr-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Root cause:infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
At1 year 3 months from the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon revised the 5.5 x 40mm rods to rods of the same size, revised the 6x45mm pedicle screws to the same size pedicle screws, and revised the 6x50mm pedicle screw to a 7x45mm pedicle screw.The surgery was completed successfully.

• Brand Name: M.U.S.T. RODS
• Common Device Name: BENT ROD TI 5.5 X 40MM - STERILE
• 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: 24738810
• Report Number: 3005180920-2026-00262
• Device Sequence Number: 9835747
• Product Code: KWP
• UDI-Device Identifier: 07630030835506
• UDI-Public: 07630030835506
• Combination Product (Y/N): N
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/31/2026

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: 03.50.451
• Device Lot Number: 2323976
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• 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 Age: 81 YR
• Patient Sex: Female
• Patient Race: White