MAUDE Adverse Event Report: ORTHOFIX INC FIREBIRD SPINAL FIXATION SYSTEM; 140MM ROD

Model Number	52-2140
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/11/2015
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that patient had l2-s1 fusion in 2013 using (2) 140mm rods.Extension surgery was performed after a fall using (2) 100mm rods from l2-t12.In (b)(6) 2015, x-rays revealed that one of the 140mm rods had broke in situ.Revision surgery was performed to remove all rods and replaced with (2) 450mm rods.
Event or Problem Description
Information provided states that patient had l2-s1 fusion in 2013 using (2) 140mm rods.Extension surgery was performed after a fall using (2) 100mm rods from l2-t12.The (b)(6) 2015 x-rays revealed that one of the 140mm rods had broke in situ.Revision surgery was performed to remove all rods and replaced with (2) 450mm rods.

• Brand Name: FIREBIRD SPINAL FIXATION SYSTEM
• Common Device Name: 140MM ROD
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 5475474
• Report Number: 3008524126-2016-00004
• Device Sequence Number: 401661
• Product Code: NKB
• UDI-Device Identifier: 18257200016051
• UDI-Public: 18257200016051
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K081684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2016

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: Lay User/Patient
• Device Model Number: 52-2140
• Device Lot Number: D477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2016
• Supplement Report FDA Received Date: 05/16/2016
• 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
• Patient Age: 69 YR