MAUDE Adverse Event Report: ORTHOFIX INC JANUS MIDLINE FIXATION SCREW; 6.5MM X 45MM MODULAR BONE SCREW SELF-TAPPING (CANNULATED

Model Number	77-8645
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Malfunction
Event or Problem Description
Based on the information provided, two (2) weeks post-op the patient fell and the head of the screw disassociated from the screw.The revision surgery was performed to remove the device.

• Brand Name: JANUS MIDLINE FIXATION SCREW
• Common Device Name: 6.5MM X 45MM MODULAR BONE SCREW SELF-TAPPING (CANNULATED
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 5525238
• Report Number: 3008524126-2016-00007
• Device Sequence Number: 13535826
• Product Code: NKB
• UDI-Device Identifier: 18257200114566
• UDI-Public: 18257200114566
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2016

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: Lay User/Patient
• Device Model Number: 77-8645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2016
• 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
• Patient Weight: 136