MAUDE Adverse Event Report: ORTHOFIX INC SPINAL FIXATION SYSTEM; SFS MULTI-AXIAL SCREW

Model Number	56-3635
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/19/2015
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that the pressure cap came off of the screw during a case.The surgeon removed the screw and placed another of the same size.

• Brand Name: SPINAL FIXATION SYSTEM
• Common Device Name: SFS MULTI-AXIAL SCREW
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 5432488
• Report Number: 3008524126-2016-00001
• Device Sequence Number: 519493
• Product Code: KWQ
• UDI-Device Identifier: 18257200055739
• UDI-Public: 18257200055739
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K081684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2016

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: 56-3635
• Device Lot Number: O06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2016
• Initial Report FDA Received Date: 02/11/2016
• 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