MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF TRANSFORAMINAL INTERBODY FUSION DEVICE TIPEEK 12X30X11 L5°; SPINE INTERVERTEBRAL BODY

Model Number	03.23.153
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Cage and screws at l5/s1 were revised 1 year and 2 months after primary following pseudarthrosis and posterior migration of the cage which eventually caused radiculopathy.
Additional Manufacturer Narrative
Batch review performed on 24 january 2022: lot 1921430: (b)(4) items manufactured and released on 03-mar-2020.Expiration date: 2025-02-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medical affairs director: one year after l5-s1 stabilization surgery with transforaminal cage and posterior instrumentation, the cage backs out and requires substitution.Developmental instability is a possible adverse event following lumbar stabilization, described in literature.The cause is often to be sought in insufficient compression remaining on the cage after a few months.The fact that the screws were changed to larger ones gives the suspect that insufficient stability was achieved by the posterior fixation system and this did not allow the cage to remain secured in place.We do not see any reason to suspect a faulty device.
Additional Manufacturer Narrative
Batch review performed on 24 january 2022: lot 1921430: (b)(4) items manufactured and released on 03-mar-2020.Expiration date: 2025-02-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medical affairs director: one year after l5-s1 stabilization surgery with transforaminal cage and posterior instrumentation, the cage backs out and requires substitution.Developmental instability is a possible adverse event following lumbar stabilization, described in literature.The cause is often to be sought in insufficient compression remaining on the cage after a few months.The fact that the screws were changed to larger ones gives the suspect that insufficient stability was achieved by the posterior fixation system and this did not allow the cage to remain secured in place.We do not see any reason to suspect a faulty device.
Event or Problem Description
Cage and screws at l5/s1 were revised 1 year and 2 months after primary following pseudarthrosis and posterior migration of the cage which eventually caused radiculopathy.

• Brand Name: MECTALIF TRANSFORAMINAL INTERBODY FUSION DEVICE TIPEEK 12X30X11 L5°
• Common Device Name: SPINE INTERVERTEBRAL BODY
• 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: 13504901
• Report Number: 3005180920-2022-00091
• Device Sequence Number: 3743719
• Product Code: MAX
• UDI-Device Identifier: 07630030829307
• UDI-Public: 07630030829307
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K200551
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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): 02/10/2022

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: 02/05/2025
• Device Model Number: 03.23.153
• Device Catalogue Number: 03.23.153
• Device Lot Number: 1921430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2020
• 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: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 73 KG