MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF TRANSFORAMINAL CAGE 12X30X9 L5; TRANSFORAMINAL PEEK CAGE

Catalog Number 03.23.052

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2015

Event Type  Injury  

Event Description

A banana cage implant could not be placed in a satisfactory manner but it was left in the patient.The surgeon decided to use a competitor product for the 2nd level.

• Brand Name: MECTALIF TRANSFORAMINAL CAGE 12X30X9 L5
• Type of Device: TRANSFORAMINAL PEEK CAGE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; castel san pietro ; SZ
• Manufacturer (Section G): MEDACTA USA INC.; 1556 w carroll ave; chicago IL 60607 000
• Manufacturer Contact: 1556 w carroll ave; chicago, IL 60607-0000
• MDR Report Key: 4878409
• MDR Text Key: 6259762
• Report Number: 3006639916-2015-00135
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 03.23.052
• Device Lot Number: 111748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2015
• Distributor Facility Aware Date: 06/26/2015
• Device Age: 43 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other