MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF OBLIQUE (TI PEEK) OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X; SPINE OBLIQUE INTERBODY FUSION DEVICE TI PEEK

Catalog Number	03.26.045
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Surgery was performed at l4-l5.After inserting the mectalif oblique (ti peek) cage, when the surgeon was trying to adjust the position by using the final impactor (ref03.22.10.0263), he discovered that the thread of the cage was damaged.The remover could not be connected with the cage anymore.Competitor's instrument were used to remove the damaged cage and a new cage was implanted.Delay time 1 hour (total time of the surgery 5 hours).
Additional Manufacturer Narrative
Batch review performed on 09 febr 2024 lot 1921457: (b)(4) items manufactured and released on 06-nov-2020.Expiration date: 2025-10-15.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.Preliminary analysis performed by r&d project manager according to the information received, the implant was inserted too ventral and so the surgeon tried to move it backward.At that time, he discovered that it was not possible to connect the cage with the remover because the posterior m4 thread was damaged.Because of that, he decided to remove the device and the cage was broken during the attempt.The posterior m4 thread was deformed probably due to the suboptimal mounting of the related inserter that caused a damage to the thread itself.The cages are checked both during the production and, after the coating, at 100% with an m4 go-nogo gauge.For these reasons, we can state that the deformation occurred after the unpackaging during the surgery.The root cause can be considered the suboptimal mounting of the related inserter on the implant.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager.The cage ref 03.26.045, lot 1921457 appears broken into three pieces.According to the information received, the implant was inserted too ventral and so the surgeon tried to move it backward.At that time, he discovered that it was not possible to connect the cage with the remover because the posterior m4 thread was damaged.Because of that, he decided to remove the device and the cage was broken during the attempt.The posterior m4 thread was deformed probably due to the incorrect mounting of the related inserter that caused a damage to the thread itself.The cages are checked both during the production and, after the coating, at 100% with an m4 go-nogo gauge.For these reasons, we can state that the deformation occurred after the unpackaging during the surgery.The root cause can be considered the incorrect mounting of the related inserter on the implant.

• Brand Name: MECTALIF OBLIQUE (TI PEEK) OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X
• Common Device Name: SPINE OBLIQUE INTERBODY FUSION DEVICE TI PEEK
• 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: 18807331
• Report Number: 3005180920-2024-00104
• Device Sequence Number: 7294693
• Product Code: MAX
• UDI-Device Identifier: 07630030830648
• UDI-Public: 07630030830648
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/15/2025
• Device Catalogue Number: 03.26.045
• Device Lot Number: 1921457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2020
• 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: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian