MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF POSTERIOR (TI PEEK) INTERBODY FUSION DEVICE PEEK/TI; SPINE INTERBODY CAGE

Model Number	03.27.007
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 may 2020: lot 1921791: (b)(4) items manufactured and released on 30-sep-2019.Expiration date: 2024-09-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed on the 12 june 2020 by medacta medical affairs director: one of the posterior intervertebral cages backed out in an elderly patient few weeks after primary surgery.Cage backout is a possible adverse event following lumbar arthrodesis, described in literature.From the information received, we have no reason to suspect a faulty device.
Event or Problem Description
Primary surgery was performed on (b)(6).Plif surgery was performed at l5-s1.The surgeon discovered the backout of one cage.Revision surgery was performed on may 13.The surgeon removed the both cages and replaced with the oblique cages.The pedicle screw system was not medacta.

• Brand Name: MECTALIF POSTERIOR (TI PEEK) INTERBODY FUSION DEVICE PEEK/TI
• Common Device Name: SPINE INTERBODY CAGE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10147519
• Report Number: 3005180920-2020-00320
• Device Sequence Number: 14058581
• Product Code: MAX
• UDI-Device Identifier: 07630030831492
• UDI-Public: 07630030831492
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2024
• Device Model Number: 03.27.007
• Device Catalogue Number: 03.27.007
• Device Lot Number: 1921791
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/12/2020
• 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: 88 YR