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

Model Number	03.27.148
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 august 2021: lot 1922677: (b)(4) items manufactured and released on 15-nov-2019.Expiration date: 2024-10-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
5 months after the primary the patient came in reporting pain.Post-op x-rays indicated that the cage moved into the canal post-op.The surgeon revised the cage and the surgery was completed successfully.
Event or Problem Description
Clinical evaluation was performed on (b)(6) 2021.
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs manager: cage migration occurred 5 months after surgery.A proper clinical evaluation cannot be performed as no radiographic image is available.Cage migration is a possible adverse event following interbody stabilization, described in literature.In this case it seems that the cause may be insufficient compression, perhaps enhanced by the use of one cage only.However no conclusion can be drawn on the basis of elements at hand.

• Brand Name: MECTALIF POSTERIOR INTERBODY FUSION DEVICE PEEK/TI
• Common Device Name: SPINE INTERBODY FUSION DEVICE
• 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: 12517833
• Report Number: 3005180920-2021-00768
• Device Sequence Number: 4584499
• Product Code: MAX
• UDI-Device Identifier: 07630040719780
• UDI-Public: 07630040719780
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2021

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: 10/23/2024
• Device Model Number: 03.27.148
• Device Catalogue Number: 03.27.148
• Device Lot Number: 1922677
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2019
• 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