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

Catalog Number 03.27.033

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2017

Event Type  Injury  

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 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°
• Type of Device: POSTERIOR INTERBODY FUSION DEVICE
• 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, 6874 ; SZ 6874
• MDR Report Key: 7057542
• MDR Text Key: 92853268
• Report Number: 3005180920-2017-00702
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07630030831751
• UDI-Public: 07630030831751
• 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: Other
• Type of Report: Initial
• Report Date: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2021
• Device Catalogue Number: 03.27.033
• Device Lot Number: 1620432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/19/2017
• 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): Other