MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI; CAGE

Catalog Number	03.27.006
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 09 january 2019 lot 1720593: (b)(4) items manufactured and released on 13 september 2017.Expiration date: 2022-09-04.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.Other device involved: mectalif assy inner shaft short reference 03.22.10.0070.Lot 1413337: (b)(4) items manufactured and released on 16 february 2015.No anomalies found related to the issue.To date, no similar event on the same lot has been registered.Investigation performed by r&d department on january 08, 2019 considering the picture attached in the complaint and the analysis performed during the visual inspection, it's possible to see that the m4 thread of the cage is slightly damaged.The damaging is probably due to a cross-threading during the inner shaft assembling.Even if there is a small damaging to the thread, with a correct assembling of the related inserter 03.22.10.0261 and inner shaft 03.22.10.0070, the functionality of the cage is not compromised.
Event or Problem Description
The nurse was not able to engage the cage with the inserter straight.The surgery was finished with the back up implant.Due to this event the surgery was prolonged about 5 minutes.The surgery was completed successfully.

• Brand Name: MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI
• Common Device Name: CAGE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8230881
• Report Number: 3005180920-2018-01079
• Device Sequence Number: 19070029
• Product Code: MAX
• UDI-Device Identifier: 07630030831485
• UDI-Public: 07630030831485
• 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
• Report Date (Section B): 01/09/2019

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: 09/04/2022
• Device Catalogue Number: 03.27.006
• Device Lot Number: 1720593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 01/09/2019
• 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