MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW REDUCTION PEDICLE SCREW 4.5X40

Model Number 03.50.705

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 12/22/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 03 january 2020.Lot 1821398: (b)(4) items manufactured and released on 03-aug-2018.Expiration date: 2023-07-22.No anomalies found related to the problem.Mto date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

The patient came in, 13 days after primary surgery, due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and the surgery was completed successfully.

• Brand Name: PEDICLE SCREW REDUCTION PEDICLE SCREW 4.5X40
• Type of Device: 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: 9605380
• MDR Text Key: 176247695
• Report Number: 3005180920-2019-01158
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630030805417
• UDI-Public: 07630030805417
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153664
• 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: 01/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2023
• Device Model Number: 03.50.705
• Device Catalogue Number: 03.50.705
• Device Lot Number: 1821398
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/20/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2018
• 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