MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW MUST MC SCREW Ø6X40 REDUCTION CANN.; SPINE PEDICLE SCREW

Model Number 03.58.644

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 03/03/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 08 march 2022.Lot 2120121: (b)(4) items manufactured and released on 06-oct-2021.Expiration date: 2026-sep-19.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 Description

At about 1 month and a half after the primary, the patient came in reporting pain due to a loose l5 screw that occurred from exercising.The surgeon revised the screw and the surgery was completed successfully.

• Brand Name: PEDICLE SCREW MUST MC SCREW Ø6X40 REDUCTION CANN.
• Type of Device: SPINE PEDICLE 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: 14012348
• MDR Text Key: 288585377
• Report Number: 3005180920-2022-00223
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630971296169
• UDI-Public: 07630971296169
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210427
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 03.58.644
• Device Catalogue Number: 03.58.644
• Device Lot Number: 2120121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2021
• 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 Sex: Male