MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X8 L5°

Catalog Number	03.27.033
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 07 november 2017 the r and d project manager performed a preliminary investigation and commented as follows: no pictures of the devices or of the devices assembled with the related inserter have been provided.For this reason based on the description mentioned in the complaint, it seem that there are problem during the implant assembling.Anyway it's not possible to identify a route cause of the event.The inserter was use to finalize the surgery with a different implant lot, for this reason the functionality of the inserter seems to be proven.On the other side the cage was produce according to the specification and no annotation have been filed in the route card.For all the reasons mentioned above it's not possible to identify a specific route cause of the event.Batch review performed on 20 november 2017.(b)(4).
Event or Problem Description
Two posterior cages were not able to fix straight to the handle (lot unknown).The surgeon replaced with new cages of a different lot.The surgery was prolonged about 10 minutes.The issue consisted in a suboptimal coupling between cages and instruments (no implant/ instrument deformation nor damage).The surgery was completed with the same instruments.

• Brand Name: MECTALIF POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X8 L5°
• Common Device Name: POSTERIOR INTERBODY FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7057542
• Report Number: 3005180920-2017-00702
• Device Sequence Number: 1157106
• Product Code: MAX
• UDI-Device Identifier: 07630030831751
• UDI-Public: 07630030831751
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2017

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: 12/19/2021
• Device Catalogue Number: 03.27.033
• Device Lot Number: 1620432
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/24/2017
• 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