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

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 05/09/2012

Event Type  malfunction  

Event Description

Surgeon reported that a valeo c cervical implant had subsided and he performed a revision surgery.

• Brand Name: VALEO C
• 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: 4620429
• MDR Text Key: 5764879
• Report Number: 3005032068-2015-00004
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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