MAUDE Adverse Event Report: ORTHOFIX INC AZURE ANTERIOR CERVICAL PLATIING SYSTEM; AZURE SELF DRILLING SCREW

Model Number 86-6014

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2016

Event Type  malfunction  

Event Description

Information provided states that 3 weeks post-op the x-rays show that the screw has backed out.Pt experienced no symptoms related to the implant.The screw remains implanted.

• Brand Name: AZURE ANTERIOR CERVICAL PLATIING SYSTEM
• Type of Device: AZURE SELF DRILLING SCREW
• 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: 5728280
• MDR Text Key: 48446455
• Report Number: 2183449-2016-00014
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130825
• 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: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 86-6014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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 Age: 59 YR
• Patient Weight: 91