MAUDE Adverse Event Report: AMEDICA CORPORATION (NOW SINTX TECHNOLOGIES) VALEO C SPINAL SPACER; INTERVERTEBRAL FUSION DEVICE

Model Number	VALEO C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant was returned to the manufacturer and evaluated.The evaluation leads one to believe that fusion occurred because there was evidence of bone growth through the implant and there was bony ingrowth on the implant surfaces.It is possible that after 3.5 years, the device became loose due to patient contraindications (e.G.Osteoporosis, infection, smoking, etc.).This adverse event was documented in the qms at the manufacturer after the event.During an internal audit done in 2018, it was discovered that form 3500a had not been successfully submitted to the fda.It appears to be lack of training on the submission process with esg and a capa was open to address this.
Event or Problem Description
The patient had the initial surgery on (b)(6) 2014 and a valeo c was implanted.In 2017, follow-up imaging showed some space between the implant and vertebrae.The valeo c implant was removed on (b)(6) 2017 by the surgeon because the implant was loose when the surgeon grabbed onto it.The surgeon communicated that there was a solid core of bone growth through the implant with some bony on growth on the superior and inferior surfaces.The surgeon removed the valeo c implant and replaced it with a vbr.

• Brand Name: VALEO C SPINAL SPACER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): AMEDICA CORPORATION (NOW SINTX TECHNOLOGIES); 1885 w 2100 south; salt lake city UT 84119
• MDR Report Key: 8368647
• Report Number: 3005032068-2017-00002
• Device Sequence Number: 1620191
• Product Code: ODP
• UDI-Device Identifier: M555110091007
• UDI-Public: M555110091007
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K091278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2014
• Device Model Number: VALEO C
• Device Catalogue Number: 11.009.1007
• Device Lot Number: 900480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2018
• Initial Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR