MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST MINI CANNULATED POLYAXIAL SCREW 4.0 X 30 FULL THREAD + NUT; SPINE CANNULATED SCREW'S SET SCREW

Model Number	03.75.210
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 july 2022: lot 2020760: (b)(4) items manufactured and released on 28-may-2020.Expiration date: 2025-05-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At about 5 months after the primary, it was observed that the set screw inserted to the c2 screw came off.The surgeon revised the screw in c2.And the surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed by medacta spine r&d project manager: during the visual inspection on retrieved implants it was observed that the set-screw were still intact with no sign of threading deformation or breakage.A sawbone was performed on the retrieved set-screw component in order to verify the overall functionality when secured with the associated polyaxial screw component.During the test it was observed a slight friction at the threading interface during advancing.However it was possible to position and secure the set-screws as per standard procedure under 3nm torque.Reverse procedure was successfully performed to remove the set-screw all the way.The test was successfully performed three time with no evidence of implants failure.Based on test result, it was possible to secure and remove the set-screw definably, according to the standard procedure and available instrumentation.The reason of loosening is unknown.It is supposed that the set-screw was not fully secured during the final procedure.

• Brand Name: MUST MINI CANNULATED POLYAXIAL SCREW 4.0 X 30 FULL THREAD + NUT
• Common Device Name: SPINE CANNULATED SCREW'S SET SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15092005
• Report Number: 3005180920-2022-00567
• Device Sequence Number: 17346883
• Product Code: NKG
• UDI-Device Identifier: 07630030863882
• UDI-Public: 07630030863882
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 11/11/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2025
• Device Model Number: 03.75.210
• Device Catalogue Number: 03.75.210
• Device Lot Number: 2020760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2020
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian