MAUDE Adverse Event Report: SYNTHES USA, LLC SYNFIX EVOLUTION; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION LUMBAR

Model Number	03.835.012S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Product slipped off device during surgery, difficult to find when covered in blood and tissue.Also product is not radiopaque so intra op xray does not detect.Fda safety report id# (b)(4).

• Brand Name: SYNFIX EVOLUTION
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION LUMBAR
• Manufacturer (Section D): SYNTHES USA, LLC; monument CO 80132
• MDR Report Key: 8785382
• Report Number: MW5088048
• Device Sequence Number: 16737773
• Product Code: OVD
• UDI-Device Identifier: 10705034814216
• UDI-Public: (01)10705034814216
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/09/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 03.835.012S
• Device Catalogue Number: 03835012S
• Device Lot Number: H870760
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention