MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST MINI MUST MINI POLYAXIAL SCREW 3.5 X 24 FULL THREAD + NUT; MUST MINI SCREW

Model Number	03.75.007
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 july 2020: lot 1822191: (b)(4) items manufactured and released on 01-mar-2019.Expiration date: 2024-02-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional items invovled in the event, batch review performed on 13 july 2020: must mini 03.75.111 must mini polyaxial screw 4.0 x 32 full thread + nut (k171369), lot.1822701.Lot 1822701: (b)(4) items manufactured and released on 14-dec-2018.Expiration date: 2023-11-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Must mini 03.75.311 must mini polyaxial screw 4.5 x 32 full thread + nut (k171369), lot.1822182.Lot 1822182: (b)(4) items manufactured and released on 26-oct-2018.Expiration date: 2023-10-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
During a post-op visit, it was observed that one set screw was disengaged from the must mini screw and two other set screws were loose.The surgeon revised the poly-axial screws at c7 and t2 with another company's product and revised the set screws in all remaining medacta poly-axial screws with medacta set screws.The surgery was completed successfully.2 set screws loose and 1 unscrewed.The two pedicle screws were revised due to the fact that the surgeon wanted a more robust construct and he implanted 2 pedicle screws and a 3.5mm - 6.0mm transition rod.The surgeon removed the set screws because he had to remove the rod so it was necessary to remove screws.The 3nm screwdriver has been used.

• Brand Name: MUST MINI MUST MINI POLYAXIAL SCREW 3.5 X 24 FULL THREAD + NUT
• Common Device Name: MUST MINI SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10269860
• Report Number: 3005180920-2020-00424
• Device Sequence Number: 3371581
• Product Code: NKG
• UDI-Device Identifier: 07630030863219
• UDI-Public: 07630030863219
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2020

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: 02/12/2024
• Device Model Number: 03.75.007
• Device Catalogue Number: 03.75.007
• Device Lot Number: 1822191
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR