MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW MUST MC SCREW Ø5.5X50 CANNULATED; SPINE PEDICLE SCREW

Catalog Number	03.58.236
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During the insertion of the must mc screw ø5.5x50 cannulated at right side of l4, the patient's vertebral body broke.Tapping 5mm and then 6mm performed.The surgeon changed the insertion point and implanted a new pedicle screw (5.5mm x 45mm).
Additional Manufacturer Narrative
Batch review performed on 05-jun-2024: lot 2126994: (b)(4) items manufactured and released on 16-feb-2022.Expiration date: 2027-02-02.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 Manufacturer Narrative
Visual inspection performed by medacta r&d spine project manager: no defect can be identified on the implant.The root cause for the pedicle fracture is unknown.

• Brand Name: PEDICLE SCREW MUST MC SCREW Ø5.5X50 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: 19654350
• Report Number: 3005180920-2024-00397
• Device Sequence Number: 15137862
• Product Code: NKB
• UDI-Device Identifier: 07630971293489
• UDI-Public: 07630971293489
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: 03.58.236
• Device Lot Number: 2126994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2022
• 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: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian