MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X7 L; SPINE INTERVERTEBRAL FUSION DEVICE

Catalog Number	03.27.006
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 25 jun 2019: lot 1820386: (b)(4) items manufactured and released on 29-nov-2018.Expiration date: 18-nov-2023.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.
Event or Problem Description
The surgeon was not able to engage straightly the mectalif tipeek posterior cage.Thread of the cage seemed to be deformed.Backup implant was used for the alternative.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection perfromed by r&d project manager on july 17th 2019: the posterior cage, ref.03.27.006, lot.1820386, presents small scratches on the surface of the ti-coating and a deformation of the m4 thread in the connection area.The potential root cause of these two defects is the cross threading due to the not correct alignment of the cage with the related inserter and inner shaft.

• Brand Name: MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X7 L
• Common Device Name: SPINE INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8784958
• Report Number: 3005180920-2019-00560
• Device Sequence Number: 19308947
• 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,Followup
• Report Date (Section B): 07/30/2019

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: 11/18/2023
• Device Catalogue Number: 03.27.006
• Device Lot Number: 1820386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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