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

Catalog Number 03.27.020

Device Problem Device Issue (2379)

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

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

Preliminary investigation performed by r and d product manager on 29 november 2017 based on the pictures attached to the case: from the pictures enclosed in the complaint of the devices are visible some titanium particle inside the thread.This particle can cause an increasing of the friction during inserter assembling.Anyway a 100% control of the thread was performed on all the part after coating without non-conformities filed in the route card.For this reasons it's not clear the route cause of the event.The same inserter was used to finalize the surgery with a different implant, for this reason the functionality of the inserter seems to be proven.Furthermore, a different part of the same lot, 153220, was used to finalize the surgery.For all the reasons mentioned above it's not possible to identify a specific route cause of the event.Batch review performed on 04 december 2017.(b)(4).

Event Description

The inner shaft did not rotate smoothly into the cage.When the surgeon aligned the shaft and turned it strongly some powder, which seemed from titanium substrate, came out from the cage.A new cage, same reference and lot, was used successfully.

Manufacturer Narrative

The implant mectalif posterior (ti peek) 03.27.020 posterior interbody fusion device peek/ti 11x25x7 l5° lot.153220 analyzed is according to the specification.The part has small scratches on coating near the corners of the implant probably due to the contact between the implant and the inserter tip.The inner shaft 03.22.10.0055/0070 can be mounted on the implant with a small friction, probably due to the debris of the coating inside the thread.Anyway it's not possible to define if the debris was already inside the thread during the first assembling.In fact, all the parts of this lot have been checked with a go/nogo gauge m4 with a positive result.Visula inspection performed of december the 19th, 2017.

• Brand Name: MECTALIF POSTERIOR INTERBODY FUSION DEVICE PEEK/TI
• 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: 7086828
• MDR Text Key: 95072723
• Report Number: 3005180920-2017-00730
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07630030831621
• UDI-Public: 07630030831621
• 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,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2022
• Device Catalogue Number: 03.27.020
• Device Lot Number: 153220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 50