MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF TRANSFORAMINAL (TI PEEK) TRANSFORAMINAL INTERBODY FUSION DEVI; SPINE INTERBODY FUSION DEVICE

Model Number	03.23.154
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
At 6 months after the primary surgery, the patient was revised due to acute lumbalgia suspected and suspicion of interbody cage migration.During the revision surgery, in a posterior approach, the cage was partially removed because was fixed and difficult to remove.After many attempts, it fractured in half and the half part of the cage was left in place.Two pedicle screws and two rods were removed.
Additional Manufacturer Narrative
Batch review performed on 26 october 2021: lot 1922798: (b)(4) items manufactured and released on 4-feb-2020.Expiration date: 2025-01-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.Visual inspection performed by medacta spine r&d manager: the two pedicle screw are according the specification and still functional.No scratches or deformation have been detected during the inspection.The tlif cage analyzed is broken in different pieces.The cage condition are due to the surgery steps in order to remove the cage, probably with partial fusion.Despite of the condition the cage seems not affected by any kind of structural failure or delamination.The root cause of the event is not clearly identifiable but it seems not related to the implant design and strength.Clinical evaluation performed by medacta medical affairs director: few months after lumbar fusion, an infection occurs and the implants are removed.The cage, accessed from the posterior side for medical reasons, is fractured during the removal process.Apparently the cause for removal is infection; at the time being, we have no reason to suspect that the adverse event was originated by one of the implanted devices.

• Brand Name: MECTALIF TRANSFORAMINAL (TI PEEK) TRANSFORAMINAL INTERBODY FUSION DEVI
• 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: 12834828
• Report Number: 3005180920-2021-00888
• Device Sequence Number: 14580362
• Product Code: MAX
• UDI-Device Identifier: 07630030829314
• UDI-Public: 07630030829314
• 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: 2021
• Device Explanted Year: 2021
• 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): 11/18/2021

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: 01/13/2025
• Device Model Number: 03.23.154
• Device Catalogue Number: 03.23.154
• Device Lot Number: 1922798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2020
• 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; Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White