MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF TRANSFORAMINAL INTERBODY FUSION DEVICE 12X30X1

Catalog Number	03.23.056
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 may 2018.Lot 148785: (b)(4) items manufactured and released on 16 june 2015.Expiration date: 2020-05-24 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.
Event or Problem Description
About 2 months after primary the cage had backed out from the vertebral body (the cage slipped and was pressing on the thecal sack).The surgeon revised the cage with another size (from 10 x 20 x 30 to 8x 12x 30).The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed on (b)(6) 2018 by r&d product manager: the mectalif transforaminal 03.23.056 lot 148785 analyzed is according to the specification in term of external dimensions.The part presents some scratches probably due to the removal of the implant.

• Brand Name: MECTALIF TRANSFORAMINAL INTERBODY FUSION DEVICE 12X30X1
• 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: 7549100
• Report Number: 3005180920-2018-00381
• Device Sequence Number: 16184888
• Product Code: MAX
• UDI-Device Identifier: 07630030829017
• UDI-Public: 07630030829017
• Combination Product (Y/N): N
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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: 05/24/2020
• Device Catalogue Number: 03.23.056
• Device Lot Number: 148785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 07/25/2018
• 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: 54 YR