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

Model Number	69-2010
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/14/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that during a case (3) three occipital screws broke and had to be left in the patient resulting in the plate being positioned further caudal than desired.

• Brand Name: CENTRUION POCT SYSTEM
• Common Device Name: OCCIPITAL BONE SCREW, PRIMARY
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 5432295
• Report Number: 3008524126-2016-00003
• Device Sequence Number: 394996
• Product Code: KWP
• UDI-Device Identifier: 18257200093007
• UDI-Public: 18257200093007
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2016

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: 69-2010
• Device Lot Number: O02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2016
• Supplement Report FDA Received Date: 04/11/2016
• 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