MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF OBLIQUE (TI PEEK) OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X

Catalog Number	03.26.044
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 21 march 2019: lot 1721469: (b)(4) items manufactured and released on 13-sep-2018.Expiration date: 2023-09-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Preliminary investigation performed by r&d project manager: from the description of the event and the pictures enclosed, the root cause of the event could be the cross threading of the inner shaft in the cage due to not correct alignment.Anyway, a confirmation of the event and a deeper analysis can be performed during the visual inspection.
Event or Problem Description
The nurse was not able to insert the cage straight with the handle.The surgery was finished with a back up implant.5 minutes of delay.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the analyzed implant has a small scratch on the back.The related inner shaft is difficult to be inserted.The potential root cause of the event is the cross-threading due to the not correct alignment of the inserter.Additional information: all the cage are checked at 100% for the inner shaft insertion before releasing.

• Brand Name: MECTALIF OBLIQUE (TI PEEK) OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X
• Common Device Name: INTERBODY FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8443624
• Report Number: 3005180920-2019-00182
• Device Sequence Number: 3056687
• Product Code: MAX
• UDI-Device Identifier: 07630030830631
• UDI-Public: 07630030830631
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2023
• Device Catalogue Number: 03.26.044
• Device Lot Number: 1721469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 04/25/2019
• 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: Other