MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. POLYAXIAL PEDICLE SCREW; PEDICLE SCREW PEDICLE SCREW 6X50

Model Number	03.50.019
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 march 2025: lot 2320177: (b)(4) items manufactured and released on 08-feb-2023.Expiration date: 2028-01-24.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.Visual inspection performed by medacta spine r&d project manager: the implant is conform.The screw has been implanted successfully in a sawbone pcf30.The cause of the loosening is not associated to the implant.Although a specific root cause cannot be confirmed, it is most likely that the unique conditions occurring during the surgical application influenced the reported issue.The investigation does not indicate any potential manufacturing related issue or systemic deficiency and the tests performed had positive results.
Event or Problem Description
Revision surgery at 1 year 8 months due to a 6mm loose screw.The surgeon implanted a 7mm and the surgery was completed successfully.

• Brand Name: M.U.S.T. POLYAXIAL PEDICLE SCREW
• Common Device Name: PEDICLE SCREW PEDICLE SCREW 6X50
• 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: 21595453
• Report Number: 3005180920-2025-00178
• Device Sequence Number: 18400701
• Product Code: MNI
• UDI-Device Identifier: 07630030834226
• UDI-Public: 07630030834226
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121115
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

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 Model Number: 03.50.019
• Device Lot Number: 2320177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White