MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF ANTERIOR STAND-ALONE TIPEEK CAGE 24X31X10 LORDOSIS 10°; INTERVERTEBRAL CAGE

Catalog Number	03.31.006
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 02 october 2018: lot 147535: (b)(4) items manufactured and released on 13 march 2018.Expiration date: 2023-02-19.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 surgeon was unable to use cages larger than 10mm in the patient.The surgeon only uses flush plates as his personal preference (compatible till 12mm cages).The surgeon implanted the cage without the plate and the cage sunk.He used the standard inserter.The surgeon spent 30 minutes to reposition it.The surgery was completed successfully.

• Brand Name: MECTALIF ANTERIOR STAND-ALONE TIPEEK CAGE 24X31X10 LORDOSIS 10°
• Common Device Name: INTERVERTEBRAL CAGE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7938074
• Report Number: 3005180920-2018-00754
• Device Sequence Number: 770832
• Product Code: OVD
• UDI-Device Identifier: 07630030833793
• UDI-Public: 07630030833793
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2023
• Device Catalogue Number: 03.31.006
• Device Lot Number: 147535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 10/05/2018
• 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: Other