MAUDE Adverse Event Report: ORTHOFIX INC CONSTRUX MINI PEEK VBR SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	45-2208
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/12/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided stated that the spacer cage broke during impaction.

• Brand Name: CONSTRUX MINI PEEK VBR SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 5993679
• Report Number: 2183449-2016-00020
• Device Sequence Number: 94806
• Product Code: MQP
• UDI-Device Identifier: 18257200038008
• UDI-Public: 18257200038008
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K051246
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2016

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: 45-2208
• Device Lot Number: D712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2016
• Initial Report FDA Received Date: 10/03/2016
• 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: Other