MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF OBLIQUE TIPEEK 10X28X15 L10°; SPINE CAGE

Catalog Number	03.26.306
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13-mar-2024.Lot 2122267: (b)(4) manufactured and released on 18-oct-2021.Expiration date: 2026-09-29.No anomalies found related to the problem.To date, one item of this lot has been sold.Clinical evaluation performed by medacta medical affairs manager: about 4 months after undergoing double-level circumferential fusion surgery with posterior screws, rods, and 2 cages, a revision surgery was required due to the lower cage backing out (mectalif oblique tipeek 10x28x15 l10°).The patient reported discomfort and underwent a follow-up x-ray that documented the cage mobilization.Upon reviewing the available pre-revision x-rays, it was evident that the lower cage had shifted posteriorly.Such migration within a short timeframe likely stemmed from inadequate primary stability that can be attributed to several possible factors: initial positioning issues, endplate preparation, undersizing or also the biological characteristics of the host bone.The revision surgery consisted in replacing the displaced cage, the previous screws and rods, and it completed successfully.We have no evidence to definitely suspect a defective or malfunctioning device.
Event or Problem Description
Revision surgery performed 4 months after the primary due to one of the cages backed out.The surgeon replaced the interbody cage and new screws were used to replace the old ones that were implanted during the primary.The surgery was completed successfully.
Event or Problem Description
Revision surgery performed 4 months after the primary due to one of the cages backed out.The surgeon replaced the interbody cage anteriorly with a competitor alif cage and then new screws (8x50) were used with a posterior approach to replace the old ones (7x50) that were implanted during the primary.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed by r&d manager: the cage ref no.(b)(4) , lot no.2122267, has various scratches on the anterior side of the implant.The scratches are compatible with the additional information received and they are related to the removal of the implant during the alif revision surgery.The cranial and caudal teeth and the rest of the implant body, instead, do not appear damaged.The root cause of the complaint (backing out of the cage) could be related to the imperfect compression applied on the implant.

• Brand Name: MECTALIF OBLIQUE TIPEEK 10X28X15 L10°
• Common Device Name: SPINE CAGE
• 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: 18894638
• Report Number: 3005180920-2024-00106
• Device Sequence Number: 15055429
• Product Code: MAX
• UDI-Device Identifier: 07630971291089
• UDI-Public: 07630971291089
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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: 09/29/2026
• Device Catalogue Number: 03.26.306
• Device Lot Number: 2122267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2021
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White