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

Catalog Number	03.23.051
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 september 2018; lot 148783: (b)(4) items manufactured and released on 12 may 2015.Expiration date: 2020-04-14; 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.Mectalif transforaminal interbody fusion device 12x30x9 l5° reference 03.23.052 (k131671); lot 114895a: (b)(4) items manufactured and released on 04 august 2017.Expiration date: 2022-07-23; 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
The patient came in complaining of pain 5 months after the primary surgery.The cages had migrated.The surgeon revised the cages.The surgery was completed successfully.

• Brand Name: MECTALIF TRANSFORAMINAL INTERBODY FUSION DEVICE 12X30X8 L°
• 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: 7876586
• Report Number: 3005180920-2018-00684
• Device Sequence Number: 228174
• 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: Non-Healthcare Professional
• Type of Report: Initial
• 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 Expiration Date: 04/14/2020
• Device Catalogue Number: 03.23.051
• Device Lot Number: 148783
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2018
• Initial 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: 47 YR