MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI; SPINE INTERVERTEBRAL CAGE

Model Number	03.27.139
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month and 3 weeks after the primary surgery, the patient came in for a post-op appointment and it was observed that a cage was backing out of disc space.The surgeon removed the cage, caps, and rod and implanted a competitor expandable cage.The existing rod was re-inserted and new caps were used to lock it down.The surgery was completed successfully.The patient did not follow post-op guidelines and the patient's lifestyle contributed to the event.
Additional Manufacturer Narrative
Batch review performed on 30-jun-2022: lot 1822376: (b)(4) items manufactured and released on 17-jun-2019.Expiration date: 2024-06-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI
• Common Device Name: SPINE INTERVERTEBRAL CAGE
• 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: 15040441
• Report Number: 3005180920-2022-00551
• Device Sequence Number: 17427947
• Product Code: MAX
• UDI-Device Identifier: 07630040719698
• UDI-Public: 07630040719698
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2024
• Device Model Number: 03.27.139
• Device Catalogue Number: 03.27.139
• Device Lot Number: 1822376
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male