MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF OBLIQUE (TI PEEK) OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12; INTERVERTEBRAL FUSION CAGE TITANIUM COATED

Catalog Number	03.26.035
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 may 2019: lot 142202: (b)(4) items manufactured and released on 17-oct-2014.Expiration date: 2019-09-30.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 director: revision due to cage migration occurred 6 months after surgery in a (b)(6) year old man.No information concerning patient general health status and activity is available.The lower endplate of l5 looks damaged in one of the radiographic views, but we do not know if it is an artefact or if the damage can have any relationship with cage migration.However, cage migration is a possible adverse event in this kind of surgery and in this case there is no particular clue that leads to think of a malfunctioning device.
Event or Problem Description
On (b)(6) 2019 we were informed about a revision performed on the following day, about 7 months after primary, due to mectalif oblique (ti peek), cage implanted at l5/5 by mis tlif technique, backward migration.The cage has been replaced successfully with mectalif posterior cage.

• Brand Name: MECTALIF OBLIQUE (TI PEEK) OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12
• Common Device Name: INTERVERTEBRAL FUSION CAGE TITANIUM COATED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8612059
• Report Number: 3005180920-2019-00369
• Device Sequence Number: 2003491
• Product Code: MAX
• UDI-Device Identifier: 07630030830556
• UDI-Public: 07630030830556
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2019

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: 09/30/2019
• Device Catalogue Number: 03.26.035
• Device Lot Number: 142202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR