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

Catalog Number	03.27.020
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: POSTERIOR INTERBODY FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7086828
• Report Number: 3005180920-2017-00730
• Device Sequence Number: 16514817
• Product Code: MAX
• UDI-Device Identifier: 07630030831621
• UDI-Public: 07630030831621
• 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,Followup
• Report Date (Section B): 01/12/2018

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: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/12/2018
• 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
• Patient Age: 75 YR
• Patient Weight: 50