MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT; SPINE CERVICAL POLYAXIAL SCREW

Model Number	03.75.001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08-mar-2022.Lot 2024025: (b)(4) items manufactured and released on 12-feb-2021.Expiration date: 2026-01-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional components involved: must mini 03.75.001 must mini polyaxial screw 3.5 x 12 full thread + nut (k171369) lot 2022688: (b)(4) items manufactured and released on 01-dec-2020.Expiration date: 2025-11-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Must mini 03.75.001 must mini polyaxial screw 3.5 x 12 full thread + nut (k171369) lot 2022689: (b)(4) items manufactured and released on 01-dec-2020.Expiration date: 2025-11-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Must mini 03.75.600 must mini rod ti ø3.5 x 80mm (sterile) (k171369) lot 2120405: (b)(4) items manufactured and released on 01-jun-2021.Expiration date: 2026-05-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Must mini 03.75.600 must mini rod ti ø3.5 x 80mm (sterile) (k171369) lot 2122213: (b)(4) items manufactured and released on 05-jul-2021.Expiration date: 2026-06-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
During a follow-up visit, 1 month after the primary surgery, it was discovered that the implanted right rod was displaced to the cranio-caudal side.During the revision surgery, it was also found that the set screws were loose on the left side as well, so, all the screws and rods were replaced.
Additional Manufacturer Narrative
Devices returned on 15-mar-2022 and analyzed on 17-mar-2022.Visual inspection performed by r&d project manager during the visual inspection of retrieved implants, it was observed that the set screws were still intact with no sign of threading deformation or other signs of damage.Additionally, all the retrieved set-screws were assembled into the polyaxial screw head in a sawbones model and fixed as per the standard procedure for testing with associated instruments.They were fixed under 3nm torque and released as per the reverse procedure.This step was repeated two times in order to investigate a possible failure mode under repeated usage.The test was successfully performed without evidence of implants failure.The screws worked well as per new virgin screws.

• Brand Name: MUST MINI POLYAXIAL SCREW 3.5 X 12 FULL THREAD + NUT
• Common Device Name: SPINE CERVICAL POLYAXIAL 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: 13693886
• Report Number: 3005180920-2022-00158
• Device Sequence Number: 4623560
• Product Code: NKG
• UDI-Device Identifier: 07630030863158
• UDI-Public: 07630030863158
• 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: 2021
• 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): 04/11/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2025
• Device Model Number: 03.75.001
• Device Catalogue Number: 03.75.001
• Device Lot Number: 2024025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian