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

Catalog Number	03.27.008
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/07/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: POSTERIOR CAGE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7163359
• Report Number: 3005180920-2017-00816
• Device Sequence Number: 16632313
• Product Code: MAX
• UDI-Device Identifier: 07630030831508
• UDI-Public: 07630030831508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2022
• Device Catalogue Number: 03.27.008
• Device Lot Number: 1620829
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 01/04/2018
• 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