MAUDE Adverse Event Report: ORTHOFIX INC CONSTRUX - PEEK VBR; CONSTRUX VBR 28MM LORDOTIC LATERAL SPACER

Model Number	45-3312
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2016
Type of Reportable Event	Malfunction
Event or Problem Description
During the initial surgery the lordotic lateral spacer broke resulting in an unspecified delay in the case.The doctor removed the spacer and placed another of same size.No adverse effects to the patient.Incident deemed reportable based on previous incident.

• Brand Name: CONSTRUX - PEEK VBR
• Common Device Name: CONSTRUX VBR 28MM LORDOTIC LATERAL SPACER
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 5878640
• Report Number: 2183449-2016-00017
• Device Sequence Number: 10767901
• Product Code: MQP
• UDI-Device Identifier: 18257200038640
• UDI-Public: 18257200038640
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K060350
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 45-3312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2016
• Initial Report FDA Received Date: 08/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1