MAUDE Adverse Event Report: AMEDICA CORP. VALEO TL; INTERBODY FUSION DEVICE

Catalog Number 11.011.1015

Device Problem Malposition of Device (2616)

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

Event Date 05/09/2012

Event Type  malfunction  

Event Description

Surgeon noticed post-op that the implant was on its side.The implant was left in that position.

Manufacturer Narrative

Device was not removed.

• Brand Name: VALEO TL
• Type of Device: INTERBODY FUSION DEVICE
• Manufacturer (Section D): AMEDICA CORP.; salt lake city UT
• Manufacturer Contact: william jordan, director ra ; 1885 w 2100 s; salt lake city, UT 84119 ; 8018393562
• MDR Report Key: 4620439
• MDR Text Key: 5653415
• Report Number: 3005032068-2015-00003
• Device Sequence Number: 1
• Product Code: ODP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2014
• Device Catalogue Number: 11.011.1015
• Device Lot Number: 900334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1