MAUDE Adverse Event Report: ORTHOFIX INC CENTURION POCT SYSTEM; OCCIPITAL BONE SCREW, PRIMARY

Model Number	69-2012
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that during a case, the first occiputal screw implanted broke during insertion resulting in a delay in the case.The implanted threads were removed from the occiput.

• Brand Name: CENTURION POCT SYSTEM
• Common Device Name: OCCIPITAL BONE SCREW, PRIMARY
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 6090502
• Report Number: 2183449-2016-00022
• Device Sequence Number: 839611
• Product Code: KWP
• UDI-Device Identifier: 18257200092895
• UDI-Public: 18257200092895
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2016

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: 69-2012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2016
• Initial Report FDA Received Date: 11/09/2016
• 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: 65 YR