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

Model Number 77-8645

Device Problem Detachment Of Device Component (1104)

Patient Problem Fall (1848)

Event Type  malfunction  

Event 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
• Type of Device: 6.5MM X 45MM MODULAR BONE SCREW SELF-TAPPING (CANNULATED
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• Manufacturer (Section G): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• Manufacturer Contact: yolanda thompson ; 3451 plano parkway; lewisville, TX 75056 ; 2149372291
• MDR Report Key: 5525238
• MDR Text Key: 41530797
• Report Number: 3008524126-2016-00007
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 18257200114566
• UDI-Public: 18257200114566
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 77-8645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 136