MAUDE Adverse Event Report: SINTX TECHNOLOGIES (FORMERLY AMEDICA CORP) VALEO AND VALEO II; VALEO AND VALEO II IBFDS

Device Problem Malposition of Device (2616)

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown valeo / valeo ii c cervical interbody fusion device.A complaint investigation was initiated.The product is not available for investigation.Part and lot numbers are unknown and devices were not returned to manufacturer for additional review or investigation.Without a lot number the device history records review could not be completed.Based on the information available, it has been determined no corrective or preventive action is proposed.The complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.The device was used for treatment not diagnosis.

Event Description

This report is being filed after the review of following journal article, calvert gc, huffmon gv 3rd, rambo wm jr, smith mw, mcentire bj, bal bs.Clinical outcomes for anterior cervical discectomy and fusion with silicon nitride spine cages: a multicenter study.J spine surg 2019;5(4):504-519.Doi: 10.21037/jss.2019.11.17.The aim of this retrospective clinical study was to collect patient demographics, comorbidities, and clinical outcomes of valeo and valeo ii cervical implants at four centers in the usa and compare the silicon nitride implant outcomes to outcomes in published literature.A total of 1,428 silicon nitride intervertebral body fusion devices were implanted during single- and multi-level acdf procedures.Of 860 patients studied, the majority received multilevel procedures.Patient follow-up averaged 10.6 months (±10.8 months).When compared to other published acdf studies, the silicon nitride patients of the present study were older, with a higher incidence of comorbidities, particularly those related to obesity, hypertension, and diabetes.The complication rate of the silicon nitride patients was 7.4% compared to 9.8% for the metadata (p=0.17).The article did not specify which of the devices were being used to the capture the following complications.There were two secondary surgical interventions (ssi) for the silicon nitride patients.Revision surgeries were performed on two patients, one for malposition and back-out of a screw and one revision of an unresolved hematoma.

• Brand Name: VALEO AND VALEO II
• Type of Device: VALEO AND VALEO II IBFDS
• Manufacturer (Section D): SINTX TECHNOLOGIES (FORMERLY AMEDICA CORP); 1885 west 2100 south; salt lake city UT 84121
• Manufacturer (Section G): SINTX TECHNOLOGIES; 1885 w 2100 south; salt lake city UT 84121
• Manufacturer Contact: jason parberry ; 1885 w 2100 south; salt lake city,
• MDR Report Key: 9611914
• MDR Text Key: 189985348
• Report Number: 3005032068-2019-00001
• Device Sequence Number: 1
• Product Code: ODP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2019
• 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
• Patient Outcome(s): Required Intervention