MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM; PEDICLE SCREW MUST MC SCREW Ø 6.5X40 CANNULATED

Model Number	03.58.254
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No analysis has been possible with the available info.A follow up mdr will be performed when/if new info will be available.
Event or Problem Description
The patient undergone primary surgery on the (b)(6) 2024.Revision surgery will be performed due to a medial deviation of l5 pedicle screw.No additional info available at now.
Event or Problem Description
The patient undergone primary surgery on (b)(6) 2024.Revision surgery has been performed on (b)(6) due to a medial deviation of l5 pedicle screw.Pedicle screw and connectors revised successfully.
Additional Manufacturer Narrative
Batch review performed on 7-nov-2024.Lot: 2321448: (b)(4) items manufactured and released on 17-may-2023.Expiration date: 2028-04-19.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.Additional implants involved: pedicle screw 03.50.204 must combined setscrew h4-t27 - (4x) k171758 lot: 2458441.Batch review performed on 07-nov-2024.(b)(4) items manufactured and released on 24-apr-2024.Expiration date: 2029-04-01.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: based on the information available no definitive root cause can be established, while 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.Updated fields: date of the event, event description, brand name, common device name, product code, model, lot, expiry date, udi, manufacturing date, additional manufacturer narrative.

• Brand Name: M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
• Common Device Name: PEDICLE SCREW MUST MC SCREW Ø 6.5X40 CANNULATED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; CH 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: 20369755
• Report Number: 3005180920-2024-00800
• Device Sequence Number: 6878213
• Product Code: NKB
• UDI-Device Identifier: 07630971293663
• UDI-Public: 07630971293663
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K210427
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: 03.58.254
• Device Lot Number: 2321448
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2023
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 43 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian