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

Model Number	03.27.113
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 april 2023.Lot 2124065: (b)(4) items manufactured and released on 22-dec-2021.Expiration date: 2026-dec-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Visual inspection performed by r&d project manager: the cage 03.27.113 lot 2124965 doesn't present evident cracks or damage either on the body or on the pyramids.The cage 03.27.034 lot 148855a presents some scratches and coating delamination on the posterior side of the implant and the thread is damaged at the very beginning.The pyramids appear damaged on one of the endplates while the ones on the other are not.According to the information provided the fecectomy was performed only on the right side and then both implants were inserted (in order, the plif 11mm & then the plif 9mm).The root cause of the complaint could be related to the non-sufficient compression applied to the implants.Clinical evaluation performed by medical affairs director: few weeks after 2-level primary stabilization surgery with pedicle screws and cages, one of the posterior cages backs out.At l4-l5, posterior cages were chosen.One had a width of 11 mm and one of 9.The narrower backed out in few weeks.The most plausible causes for cage migration include insufficient compression, patient behaviour, difficulties in plate preparation.No reason to suspect a faulty device.Additional item involved in the event, batch review performed on 2 may 2023.Mectalif posterior (ti peek) 03.27.034 posterior interbody fusion device peek/ti 11x22x10 l5° (k133192) lot.148855a.Lot 148855a: (b)(4) items manufactured and released on 01-mar-2021.Expiration date: 2026-feb-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
Revision surgery performed due to cages migration in l4-l5, about 1 month after the primary surgery.

• Brand Name: MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI
• Common Device Name: POSTERIOR INTERBODY FUSION DEVICE PEEK/TI
• 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: 17001454
• Report Number: 3005180920-2023-00368
• Device Sequence Number: 20407167
• Product Code: MAX
• UDI-Device Identifier: 07630040719438
• UDI-Public: 07630040719438
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 05/25/2023

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 Model Number: 03.27.113
• Device Catalogue Number: 03.27.113
• Device Lot Number: 2124965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian