MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST MINI CANNULATED POLYAXIAL SCREW 4.0 X 24 FULL THREAD + NUT

Model Number	03.75.207
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	05/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 may 2021.Lot 1922066: (b)(4) items manufactured and released on 12-aug-2019.Expiration date: 2024-07-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with another similar reported event.Note that two devices with the same lot number were reported in this case.
Event or Problem Description
C3-c6 surgery performed on (b)(6) 2021.After the surgery, the patient's right leg movement was no good.The surgeon checked with ct and mri images, but the pedicle screw implantation did not indicate any problems.The surgeon informed (b)(6) evening that the right leg movement did not recover, so the patient moved to another hospital and the surgeon removed pedicle screws in order to perform the decompression the same day of primary surgery.The reason for this event is still unknown.

• Brand Name: MUST MINI CANNULATED POLYAXIAL SCREW 4.0 X 24 FULL THREAD + NUT
• Common Device Name: CANNULATED POLYAXIAL SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12023463
• Report Number: 3005180920-2021-00502
• Device Sequence Number: 14677296
• Product Code: NKG
• UDI-Device Identifier: 07630030863851
• UDI-Public: 07630030863851
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2021

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: 07/14/2024
• Device Model Number: 03.75.207
• Device Catalogue Number: 03.75.207
• Device Lot Number: 1922066
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/18/2021
• 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