MAUDE Adverse Event Report: AMEDICA VALEO OL/PL SPINE FUSION; BONE CHISEL

Model Number 91.004.3710

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/05/2014

Event Type  malfunction  

Event Description

A medica box chisel sets for valeo ol/pl spine fusion designed with small interior ridges that make adequate clearing very difficult and questionable.Item found with bone debris intraoperatively.Took multiple attempts, under high magnification to adequately clean bone fragments.Design reflected in all chisels in this series.

• Brand Name: VALEO OL/PL SPINE FUSION
• Type of Device: BONE CHISEL
• Manufacturer (Section D): AMEDICA; salt lake city UT 84119
• MDR Report Key: 3677447
• MDR Text Key: 4259773
• Report Number: MW5034917
• Device Sequence Number: 1
• Product Code: EML
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 91.004.3710
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR