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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/16/2019

Event Type  Injury  

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 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
• Type of Device: INTERVERTEBRAL FUSION CAGE TITANIUM COATED
• 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: 8612059
• MDR Text Key: 145126198
• Report Number: 3005180920-2019-00369
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07630030830556
• UDI-Public: 07630030830556
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133192
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 03.26.035
• Device Lot Number: 142202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR