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

Model Number	03.75.002
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02-oct-2024: lot 2229965: (b)(4) items manufactured and released on 01-feb-2023.Expiration date: 2028-01-11.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.
Event or Problem Description
During the spine surgery, a bone fracture was observed while inserting the must mini polyaxial screw 3.5 x 14.Another screw was used, also changing the screw trajectory.The surgery has been completed successfully.10 minutes delay.Total surgery time 4 hours.The bone seemd to be hard.
Additional Manufacturer Narrative
On november 05th 2024 we have received the item involved in the event.Visual inspection performed by r&d project manager.During posterior vertebra fixation technique, it is not uncommon that a portion of vertebra bone can fracture during insertion of screws.Basically, bone fracture can be reasonably affected due to the screw entering point, the screw trajectory, the specific vertebra anatomy and dimension, the related bone density, the preparation of screw path as well as the overall dimension of the screw.Based on the available information, it was assumed that the initial screw trajectory as well as the bone density were determining a potential risk for bone fracture.As reported, change of screw trajectory and screw size it was possible to position the screw without additional issue.

• Brand Name: M.U.S.T. MINI POLYAXIAL 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: 20469756
• Report Number: 3005180920-2024-00853
• Device Sequence Number: 7472155
• Product Code: NKG
• UDI-Device Identifier: 07630030863165
• UDI-Public: 07630030863165
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171369
• 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): 11/29/2024

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: 03.75.002
• Device Lot Number: 2229965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian