MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TRANSFORAMINAL INTERBODY FUSION DEVICE 12X30X8 L5°

Catalog Number	03.23.051
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018, lot 144046: (b)(4) items manufactured and released on (b)(6) 2014.Expiration date: 08/31/2019.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.Clinical evaluation performed on (b)(6) 2018 by medical affairs director expulsion of a tlif cage at l4-l5 one month after operation.This cage was used to replace a former (larger) similar cage that incurred into the same adverse event.It was substituted by an alif cage.There is no clue that the problem was originated by a faulty or malfunctioning device.Cage expulsion is a known, possible adverse event following interbody fusion surgery, described in literature.Preliminary investigation performed by r&d spine director on (b)(6) 2018: implant migration can occur among others because of a too small implant size selection.
Event or Problem Description
The patient had a primary on (b)(6) 2018.On (b)(6) 2018 the surgeon revised the patient cage because slipped and was pressing on the thecal sack, with a smaller cage (mdr 2018-00381).Also the 2nd cage slipped and was pressing on the thecal sack,it migrated toward the thecal sack 1 month later.
Additional Manufacturer Narrative
Due to human error the follow up was reported not on time.Visual inspection performed by r&d project manager on 21 june 2018: the mectalif transforaminal 03.23.051, lot 144046, analyzed is according to the specification in terms of external dimensions.The part presents some scratches that are probably due to the removal of the implant.

• Brand Name: TRANSFORAMINAL INTERBODY FUSION DEVICE 12X30X8 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: 7605420
• Report Number: 3005180920-2018-00434
• Device Sequence Number: 1695677
• Product Code: MAX
• UDI-Device Identifier: 07630030828966
• UDI-Public: 07630030828966
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018

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: 08/31/2019
• Device Catalogue Number: 03.23.051
• Device Lot Number: 144046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 08/29/2018
• 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