MAUDE Adverse Event Report: AMEDICA CORPORATION (NOW SINTX TECHNOLOGIES) VALEO II PL 9MM X 25MM 6DEG; INTERVERTEBRAL FUSION DEVICE- LUMBAR

Model Number PL

Device Problem Mechanical Problem (1384)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

This event was documented in the qms at the manufacturer within 5 days afer the event.During an internal audit of the process to report adverse events it was discovered this event had not been successfully submitted to the fda on the initial attempt.It appears to be lack of training on the submission process with the esg.

Event Description

The implant broke when the surgeon was trying to insert it.

• Brand Name: VALEO II PL 9MM X 25MM 6DEG
• Type of Device: INTERVERTEBRAL FUSION DEVICE- LUMBAR
• Manufacturer (Section D): AMEDICA CORPORATION (NOW SINTX TECHNOLOGIES); 1885 w 2100 s; salt lake city UT 84119
• Manufacturer (Section G): SINTX TECHNOLOGIES; 1885 w 2100 s; salt lake city UT 84119
• Manufacturer Contact: jason parberry ; 1885 w 2100 s; salt lake city, UT 84119 ; 8018393566
• MDR Report Key: 8366225
• MDR Text Key: 137428887
• Report Number: 3005032068-2018-00002
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2018
• Device Model Number: PL
• Device Catalogue Number: 11.113.4510
• Device Lot Number: 901643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2018
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 70 YR