MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TRANSFORAMINAL INTERBODY FUSION DEVICE 12X30X12 L5° OR 12X30X11 L5°

Catalog Number	03.23.057 OR 03.23.053
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The two possible lot involved are:- lot 144050: (b)(4) items manufactured and released on 11 december 2014.Expiration date: 2019-09-30;no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.- lot 148913: (b)(4) items manufactured and released on 13 june 2015 expiration date: 2020-05-27no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed on 31 july 2018 by medical affairs (b)(4):implant mobilization occurred 2 months after implantation.Radiographic images provided show the migration of the l5-s1 cage.The initial position of the cage cannot be assessed as only pre-revision x-ray is available.The reason of this event cannot be determined but there is no discernible indication of a malfunctioning device.
Event or Problem Description
The patient came in complaining of pain.The surgeon believes that the cause of pain was due to the l5-s1 tlif cage migrating.The surgeon removed the cage and replaced it with mectalif anterior cage tipeek 24x31x14 l15°.No information about which of the two cage (ref and lot) was revised.
Additional Manufacturer Narrative
Visual inspection performed on august, the 27th 2018 by r&d product manager: the mectalif transforaminal cage 03.23.057 (lot.144050) is according to the specification.From the pictures enclosed it's possible to notice different scracthes due to the revision surgery and the removal of the cage.The revision surgery, as mentioned in the complaint, was performed by an anterior approach and, due to the fact that the tlif cage has been designed for a posterior approach and so no anterior interface, the cagehas been removed with generic instrument.The root cause of the potential migration of the cage is not foreseenable.

• Brand Name: TRANSFORAMINAL INTERBODY FUSION DEVICE 12X30X12 L5° OR 12X30X11 L5°
• Common Device Name: TRANSFORAMINAL INTERBODY FUSION DEVICE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7793280
• Report Number: 3005180920-2018-00619
• Device Sequence Number: 13820256
• Product Code: MAX
• UDI-Device Identifier: 07630030828980
• UDI-Public: 07630030828980
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2018

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 Catalogue Number: 03.23.057 OR 03.23.053
• Device Lot Number: 144050 OR 148913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 09/14/2018
• 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: Required Intervention
• Patient Age: 60 YR