MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X7 L0°

Catalog Number 03.26.034

Device Problem Material Deformation (2976)

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

Event Date 10/12/2017

Event Type  malfunction  

Manufacturer Narrative

Mectalif posterior handle (ref.03.22.10.0056.Lot unknown), mectalif oblique handle (ref.03.22.10.0262, lot unknown) and mectalif inner rod (ref.03.22.10.0055, lot unknown) were used during surgery.On (b)(6) 2017 the r and d project manager performed a visual inspection of the retrieved items and commented as follows: both the posterior and the oblique cages present damaging of the coating and scratches particularly in the back side of the devices.The posterior cage is not deformed and the threaded interface is functional.The oblique cage is deformed but the threaded interface is functional.The scratches on the back of the devices are compatible with a rotation of the implants after the fixation on the inserter.The application of a rotation movement with an high force or a not perfect fixation of the devices on the inserter can produce this kind of scratches.The damaging of the coating of both cages and the deformation of the oblique one are probably due to the removal process.Batch review performed on 09 november 2017.Mectalif posterior interbody fusion device peek/ti 11x25x7 l5°, code 03.27.020, lot.148876 (k133192) (b)(4).

Event Description

It was hard to insert the cages into the intervertebral at l4/l5, even though the surgeon tried to trial implant and distracted the dedicated size.After that the surgeon found the cage deformation.There was no delay as they used backup implants to proceed.The surgeon's comments: there is a problem of the implant inserter itself.When hitting an inserter with a hammer, the inner part was loosen.As a result, when inserting the cage into the intervertebral, appropriate force would not be added to the appropriate place.It would be the root cause of this event.

• Brand Name: MECTALIF OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X7 L0°
• Type of Device: OBLIQUE 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: 7018102
• MDR Text Key: 92924190
• Report Number: 3005180920-2017-00651
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07630030830549
• UDI-Public: 07630030830549
• 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: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2021
• Device Catalogue Number: 03.26.034
• Device Lot Number: 1620018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2016
• 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
• Patient Age: 45 YR
• Patient Weight: 103