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

Model Number 03.75.207

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Discomfort (2330)

Event Date 05/20/2021

Event Type  Injury  

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 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
• Type of Device: CANNULATED 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: 12023463
• MDR Text Key: 257167932
• Report Number: 3005180920-2021-00502
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 07630030863851
• UDI-Public: 07630030863851
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 03.75.207
• Device Catalogue Number: 03.75.207
• Device Lot Number: 1922066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention