MAUDE Adverse Event Report: ORTHOFIX INC. FIREBIRD SFS; ROD, 450MM X DIA 5.5MM, COCR

Model Number	51-2450
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that approximately 3 weeks post op it was noticed that the 450mm rod had broken.The patient is asymptomatic and a revision has not been planned at this time.

• Brand Name: FIREBIRD SFS
• Common Device Name: ROD, 450MM X DIA 5.5MM, COCR
• Manufacturer (Section D): ORTHOFIX INC.; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 7527739
• Report Number: 2183449-2018-00012
• Device Sequence Number: 13486343
• Product Code: KWP
• UDI-Device Identifier: 18257200014453
• UDI-Public: 18257200014453
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K092624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2018

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: Lay User/Patient
• Device Model Number: 51-2450
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 05/18/2018
• 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
• Patient Age: 74 YR