MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. RODS; ROD TI 5.5X200

Model Number	03.50.401
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 march 2026.Pedicle screw 03.50.401 rod ti 5.5x200 (k121115) lot 2226906: 50 items manufactured and released on 28-nov-2022.Expiration date: 2027-11-14.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 03.50.401 rod ti 5.5x200 (k121115) lot 2220469: (b)(4) items manufactured and released on 28-march-2022.Expiration date: 2027-03-06.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 03.50.032 pedicle screw 7x50 (k121115) lot 2458436: (b)(4) items manufactured and released on 22-apr-2024.Expiration date: 2029-03-24.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 03.50.032 pedicle screw 7x50 (k121115) lot 2459089: (b)(4) items manufactured and released on 15-apr-2024.Expiration date: 2029-03-24.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:no case-specific information was supplied; therefore we cannot make a well-grounded evaluation.Normally, these events are caused by fatigue loading due to the uneven distribution of the load along the construct, resulting in incomplete post-operative stabilization, or in lack of fusion - the screws and rods are temporary devices, not designed to sustain the load indefinitely, so in case of failure of fusion, fatigue fractures are almost inevitable.The investigation does not indicate any potential manufacturing-related issue or systemic deficiency.
Event or Problem Description
Revision surgery due to two rods breakage (t12-s1) and mobilization of two pedicle screws at s1, at about 1 year 8 months after the primary.

• Brand Name: M.U.S.T. RODS
• Common Device Name: ROD TI 5.5X200
• 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: 24924655
• Report Number: 3005180920-2026-00313
• Device Sequence Number: 13337038
• Product Code: KWP
• UDI-Device Identifier: 07630030835346
• UDI-Public: 07630030835346
• 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): 04/20/2026

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: 03.50.401
• Device Lot Number: 2220469
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White