MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW MUST MC SCREW Ø5.5X45 CANNULATED; SPINE MUST MC SCREW

Catalog Number	03.58.235
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 may 2024 lot 2222497: (b)(4) items manufactured and released on 20-sept-2022.Expiration date: 2027-09-01.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.Visual inspection performed by r&d manager: no defect can be seen on the screw.Diameter and length are according to specification.The root cause for the fracture of the pedicle cannot be imputed to the screw.Planning review: our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.
Event or Problem Description
During myspine l4 surgery, while the surgeon was trying to insert the must mc screw ø5.5x45 cannulated, the vertebral body cracked.Tapping 5mm and 6mm performed.The surgeon changed the entry point, and successfully inserted the screw (ø5.5x35).Patient's bone quality normal.

• Brand Name: PEDICLE SCREW MUST MC SCREW Ø5.5X45 CANNULATED
• Common Device Name: SPINE MUST MC 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: 19536388
• Report Number: 3005180920-2024-00403
• Device Sequence Number: 6425348
• Product Code: NKB
• UDI-Device Identifier: 07630971293472
• UDI-Public: 07630971293472
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K210427
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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 Catalogue Number: 03.58.235
• Device Lot Number: 2222497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian