MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. POLYAXIAL PEDICLE SCREW; ENH. CANN. PEDICLE SCREW 6X35MM + NUT (1X) STERILE

Model Number	03.52.322
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 years 10 months after the primary, the patient came in due to having two loose screws on the bottom of the spine construct and the cause is unknown.There is no indication of trauma.The surgeon revised the 40mm rods to 35mm rods and revised the two 6x35mm pedicle screws to 8x40mm pedicle screws.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 6 may 2026 lot 2228644: 70 items manufactured and released on 05-jan-2023.Expiration date: 2027-12-06.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.Root cause: based on the information available no definitive root cause can be established.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. POLYAXIAL PEDICLE SCREW
• Common Device Name: ENH. CANN. PEDICLE SCREW 6X35MM + NUT (1X) 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: 25268619
• Report Number: 3005180920-2026-00456
• Device Sequence Number: 9185536
• Product Code: NKB
• UDI-Device Identifier: 07630030857577
• UDI-Public: 07630030857577
• Combination Product (Y/N): N
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/25/2026

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: 03.52.322
• Device Lot Number: 2228644
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• 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: 71 YR
• Patient Sex: Female
• Patient Race: White