MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. RODS; PEDICLE SCREW ENH. BENT ROD TI R100 5.5X50MM

Model Number	03.52.456
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in for a post-op appointment at about 1 year and 3 months from primary.It was observed that one of the rods was broken.The surgeon revised the rods, screws, and caps and implanted with larger diameter screws and a new rod.The surgery was completes successfully.
Additional Manufacturer Narrative
Batch review performed on 06-02-2025.Lot 1620690: (b)(4) items manufactured and released on 25-01-2021.Expiration date: 2026-01-07.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.Clinical evaluation performed by medical affairs department: a revision surgery was performed 1 year and 3 months after an l3-l4 spinal fusion.The reported reason for the revision was a broken rod on one side.The available x-ray clearly shows the disengagement of the rod from the distal screw, but the exact location of the break is unclear, as the distal fragment is not clearly visible.It is possible that the fragment is obscured by other instrumentation.For example, in the anteroposterior view, a small area of radiopacity is visible between a k-wire (likely used as a reference) and the tulip of the distal screw.Determining the cause of the breakage is challenging, particularly given that the break appears to be located distally.Rod breakage in spinal surgery can sometimes occur when osseous fusion is incomplete, causing the implants, initially used as temporary stabilizers, to endure prolonged physiological mechanical stress.In this case, we do not have sufficient elements to draw definitive conclusions.
Additional Manufacturer Narrative
Visual inspection performed by r&d department from what we received there is only one part on the broken implant.On this part of the rod is present a cross-section area that is typical of a fatigue fracture.The crack propagation can be visualize through the typically striation patterns which indicate the direction of the crack growth when a rod is subjected to cyclic loading.The scope of the implant is to bear loads only for a temporary period up to the osseous fusion is complete.Probably this did not happen and the construct has been fatigue loaded during the period in which it was implanted.

• Brand Name: M.U.S.T. RODS
• Common Device Name: PEDICLE SCREW ENH. BENT ROD TI R100 5.5X50MM
• 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: 21523845
• Report Number: 3005180920-2025-00128
• Device Sequence Number: 8339432
• Product Code: MNI
• UDI-Device Identifier: 07630030859489
• UDI-Public: 07630030859489
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141988
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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: 01/07/2026
• Device Model Number: 03.52.456
• Device Lot Number: 1620690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2021
• 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