MAUDE Adverse Event Report: ORTHOFIX INC. FIREBIRD SPINE FIXATION SYSTEM; FIREBIRD TOP-LOADING BODY

Model Number	44-2101
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	05/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that patient with lumbar arthrodesis underwent successful surgery.Two weeks post-op the patient fell and began experiencing pain.X-rays revealed that the top-loading body had pulled off of the pedical screw requiring a revision surgery.

• Brand Name: FIREBIRD SPINE FIXATION SYSTEM
• Common Device Name: FIREBIRD TOP-LOADING BODY
• Manufacturer (Section D): ORTHOFIX INC.; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 6713944
• Report Number: 2183449-2017-00019
• Device Sequence Number: 210750
• Product Code: MNH
• UDI-Device Identifier: 18257200009718
• UDI-Public: 18257200009718
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K994217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 44-2101
• Device Lot Number: S176
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2017
• Initial Report FDA Received Date: 07/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR