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

Model Number	03.50.016
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Unspecified Infection (1930); Medical device site infection (4845)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.About 20 days after the primary surgery, the surgeon performed a washout and removed all implants.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 7 october 2024.Lot 1924046: 9 items manufactured and released on 04-feb-2020.Expiration date: 2025-jan-20.No anomalies found related to the problem.To date, 6 items of the same lot have been sold with no similar reported event during the period of review.Additional implants revised.Batch review performed on 7 october 2024 on pedicle screw 03.50.016 pedicle screw 6x35 (k121115) lot.2023369.Lot 2023369: 55 items manufactured and released on 11-jan-2021.Expiration date: 2025-dec-10.No anomalies found related to the problem.To date, 49 items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 7 october 2024 on pedicle screw 03.50.016 pedicle screw 6x35 (k121115) lot.2023955.Lot 2023955: (b)(4) items manufactured and released on 19-jan-2021.Expiration date: 2025-dec-20.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.Batch review performed on 7 october 2024 on pedicle screw 03.50.016 pedicle screw 6x35 (k121115) lot.2120720.Lot 2120720: (b)(4) items manufactured and released on 05-mar-2021.Expiration date: 2026-feb-17.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.Batch review performed on 7 october 2024 on pedicle screw 03.50.017 pedicle screw 6x40 (k121115) lot.2021953.Lot 2021953: (b)(4) items manufactured and released on 09-oct-2020.Expiration date: 2025-sep-23.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.Batch review performed on 7 october 2024 on pedicle screw 03.50.017 pedicle screw 6x40 (k121115) lot.2120724.Lot 2120724: (b)(4) items manufactured and released on 01-mar-2021.Expiration date: 2026-feb-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.Batch review performed on 7 october 2024 on pedicle screw 03.50.454 bent rod ti 5.5x55mm (k121115) lot.2322413.Lot 2322413: (b)(4) items manufactured and released on 17-may-2023.Expiration date: 2028-apr-30.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 (2 devices involved in this complaint).Batch review performed on 7 october 2024 on mectalif posterior (ti peek) 03.27.114 posterior interbody fusion device peek/ti 9x22x11 l5° (k181970) lot.2223875, lot 2223875: (b)(4) items manufactured and released on 30-jun-2022.Expiration date: 2027-jun-13.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 (2 devices involved in this complaint).Batch review performed on 7 october 2024 on mectalif posterior (ti peek) 03.27.114 posterior interbody fusion device peek/ti 9x22x11 l5° (k181970) lot.2226587 lot 2226587: (b)(4) items manufactured and released on 16-dec-2022.Expiration date: 2027-jun-13.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.Batch review performed on 7 october 2024 on mectalif posterior (ti peek) 03.27.114 posterior interbody fusion device peek/ti 9x22x11 l5° (k181970) lot.2228508 lot 2228508: (b)(4) items manufactured and released on 22-feb-2023.Expiration date: 2028-jan-29.No anomalies found related to the problem.To date, (b)(4) of the lot has been sold.

• Brand Name: M.U.S.T. POLYAXIAL PEDICLE SCREW
• Common Device Name: SPINE PEDICLE SCREW
• 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: 20544242
• Report Number: 3005180920-2024-00872
• Device Sequence Number: 7873193
• Product Code: MNI
• UDI-Device Identifier: 07630030834196
• UDI-Public: 07630030834196
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2024

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 Expiration Date: 01/20/2025
• Device Model Number: 03.50.016
• Device Lot Number: 1924046
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2020
• 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: Unknown