MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF TRANSFORAMINAL (PEEK) TLIF CAGE TIPEEK; SPINE INTEVERTEBRAL CAGE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/22/2021

Event Type  Injury  

Manufacturer Narrative

No additional analysis possible for lots and devices lacking.

Event Description

The surgeon reported post-op observation of possible local reaction around the implant 9 months post-op, primary details are unknown.Revision surgery was performed on the (b)(6) 2021 following a probable infection.Screws and mectalif transforaminal l4-l5 were explanted, new fenestrated pedicle screws were implanted.No cage was placed in the intervertebral space.

Manufacturer Narrative

Clinical evaluation performed by medacta medical affairs director: approx.9 months after lumbar stabilization with pedicle screws and interbody devices in an elderly male patient, the interbody cages are removed because local reaction is visible in the images and infection is suspected.After the revision surgery, it was commented by the operating surgeon that infection was most probable and that there was no need to replace the interbody devices, leaving the pedicle screws to sustain the fusion program.No reason to suspect a faulty device at the origin of this adverse event.

• Brand Name: MECTALIF TRANSFORAMINAL (PEEK) TLIF CAGE TIPEEK
• Type of Device: SPINE INTEVERTEBRAL CAGE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11855559
• MDR Text Key: 251883950
• Report Number: 3005180920-2021-00401
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR