MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF TI-PEEK POSTERIOR CAGE; POSTERIOR CAGE

Catalog Number 03.27.008

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 12/07/2017

Event Type  Injury  

Manufacturer Narrative

On 20 dec 2017 the r&d spine director added the following details: i have discussed the complaint with the sales team and they confirmed that it was a clear surgeon error and there were no problems caused by the implant or instrument.On 22 dec 17 the medical affairs director made the following analysis: after insertion of a l5-s1 interbody cage, the position was tentatively re-adjusted, but the cage fell from the intervertebral space.A new cage was added and the previous one left in the body.The prognosis of this condition is unknown because the position of the first cage is only represented in the 2d images supplied; technically, the permanence of the cage outside of the prescribed position is not a problem.There is no reason to suspect that this adverse event was caused by a faulty device.Batch review performed on 02 january 2018: lot 1620829: (b)(4) items manufactured and released on 01 september 2017.Expiration date: 2022-08-20.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

The surgeon inserted the cage at level l5/s1.After that the surgeon moved the inserted cage to external side, but the cage was dropped anterior side.The surgeon decided to make a follow-up.Therefore the dropped cage was left in the patient body.Due to this event, the surgery was prolonged about 30 minutes.

• Brand Name: MECTALIF TI-PEEK POSTERIOR CAGE
• Type of Device: POSTERIOR CAGE
• 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: 7163359
• MDR Text Key: 96339044
• Report Number: 3005180920-2017-00816
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07630030831508
• UDI-Public: 07630030831508
• 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: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2022
• Device Catalogue Number: 03.27.008
• Device Lot Number: 1620829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2017
• 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