MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW MUST MC SCREW Ø7X40 CANNULATED; SPINE PEDICLE SCREW

Model Number	03.58.264
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During myspine mc l5 surgery, at the end of the insertion of the screw, a bone fracture occurred.The surgeon felt high resistance while inserting the screw.The screw was implanted into the patient and the surgery was completed successfully.Patient's bone quality normal.Diameter for the tapping used: 5mm at first, then 6mm, finally 7 mm was used.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023.Lot 2224959: 20 items manufactured and released on (b)(6) 2022.Expiration date: 2027-09-08.No anomalies found related to the problem.To date, 2 items of the same lot have been sold without any similar reported event during the period of review.Mysolution planning review.Our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.

• Brand Name: PEDICLE SCREW MUST MC SCREW Ø7X40 CANNULATED
• 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: 16713623
• Report Number: 3005180920-2023-00271
• Device Sequence Number: 7161072
• Product Code: NKB
• UDI-Device Identifier: 07630971293762
• UDI-Public: 07630971293762
• 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: 2023
• 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): 04/11/2023

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: 03.58.264
• Device Catalogue Number: 03.58.264
• Device Lot Number: 2224959
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2022
• 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 Age: 80 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian