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

Model Number	03.27.046
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020.Lot 1822005: 70 items manufactured and released on (b)(6) 2019.Expiration date: 29-jan-2024.No anomalies found related to the problem.To date, 13 items of the same lot have been already sold without any other similar reported event.In this complaint two cages of the same lot are involved in the event.Clinical evaluation performed by medical affairs director few weeks after two-level lumbar stabilization surgery, the interbody cages were found to be mobile and therefore replaced with oblique ones.This can be due to insufficient interference of the cages with the bone or to excessive distraction between the vertebral bodies.There is no indication leading to suspect a faulty device as responsible for the need to reoperate.
Event or Problem Description
Revision surgery performed due to cages mobilization 1 month after the primary surgery.The posterior cages were replaced with an oblique cage.

• Brand Name: MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI
• Common Device Name: INTERVERTEBRAL CAGE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10553056
• Report Number: 3005180920-2020-00616
• Device Sequence Number: 11568101
• Product Code: MAX
• UDI-Device Identifier: 07630030831881
• UDI-Public: 07630030831881
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2024
• Device Model Number: 03.27.046
• Device Catalogue Number: 03.27.046
• Device Lot Number: 1822005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR