MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 6X50; SPINE PEDICLE SCREW

Catalog Number 03.50.019

Device Problem Malposition of Device (2616)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/18/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 22 january 2024: lot 2222870: (b)(4) manufactured and released on 10-may-2022.Expiration date: 2027-apr-21.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.

Event Description

The patient came in for a post-op appointment and it was observed that the implanted screw was too close to the nerve root and had to be redirected.The screw was placed freehand using c-arm.About 6 days after the primary surgery, the surgeon removed 6x50mm pedicle screw and implanted a 7x50mm pedicle screw.The surgery was completed successfully.

• Brand Name: PEDICLE SCREW 6X50
• Type of Device: SPINE PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18648848
• MDR Text Key: 334614279
• Report Number: 3005180920-2024-00030
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121115
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03.50.019
• Device Lot Number: 2222870
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2022
• 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