MAUDE Adverse Event Report: ORTHOFIX INC ASCENT POCT SYSTEM; ASCENT LE 200MM RODS

Model Number	65-2200
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that 2 rods broke into treatment.Patient had occipital to c6 surgery some time ago.Original surgery information is not available.The rods broke at the transition point at c2.The rods were removed and replaced with new rods.

• Brand Name: ASCENT POCT SYSTEM
• Common Device Name: ASCENT LE 200MM RODS
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 5645685
• Report Number: 3008524126-2016-00012
• Device Sequence Number: 10837580
• Product Code: KWP
• UDI-Device Identifier: 18257200018581
• UDI-Public: 18257200018581
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K111183
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2016

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: 65-2200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2016
• Initial Report FDA Received Date: 05/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR