MAUDE Adverse Event Report: ORTHOFIX INC ASCENT POSTERIOR OCCIPITAL THORACIC SYSTEM (TITANIUM & COBALT CHROME RODS); 3.0MM TO 5.5MM TRANSITION ROD, 200MMX200MM

Model Number	66-2020
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	06/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two 66-2020 transition rods are being reported for breakage.P/n 66-2020 lot p10 was manufactured on 07/27/2011.(b)(4).P/n 66-2020 lot p11 was manufactured on 12/21/2012.(b)(4).
Event or Problem Description
Based on the information provided, two transition rods broke in situ resulting in a revision surgery.

• Brand Name: ASCENT POSTERIOR OCCIPITAL THORACIC SYSTEM (TITANIUM & COBALT CHROME RODS)
• Common Device Name: 3.0MM TO 5.5MM TRANSITION ROD, 200MMX200MM
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 6788246
• Report Number: 2183449-2017-00024
• Device Sequence Number: 1077788
• Product Code: KWP
• UDI-Device Identifier: 18257200018765
• UDI-Public: 18257200018765
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K111183
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2017

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: 66-2020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1