MAUDE Adverse Event Report: ORTHOFIX INC AZURE ANTERIOR CERVICAL PLATE SYSTEM; 86-0246

Model Number 86-0246

Device Problem Unstable (1667)

Patient Problem Neck Pain (2433)

Event Date 06/29/2015

Event Type  malfunction  

Event Description

Information provided states that the patient had increasing neck pain after surgery in 2013.X-rays taken showed instability at c4-c5 and failed hardware at c7.Surgery was performed to remove failed hardware on (b)(6) 2015.

Manufacturer Narrative

No samples were returned.A lateral x-ray (prior to revision) was sent showing acp fixation at what appears to be c5-c6-c7 and c3-c4.The bone screws at c7 vertebral level seems to have changed trajectory and have backed out, possibly breaking the locking tab on its way out.The shape of the head appears to indicate usage of a constrained screw at this level.All other bone screws appeared to be in its originally implanted position.The c6-c7 disc space appears to be collapsed, with some indications of fractured bone.The operative/procedure report from surgeon ((b)(6) 2015) mentions that exploration revealed that the c5-c7 regions were somewhat fused but appeared to be adequate.From this report, it appears that the c5-c7 construct was left in place with the c7 screws not being replaced.Charge sheet for the original surgery ((b)(4)) showed the use of 1 rescue constrained screw (4.5mm x 16mm) and 9 primary constrained screws (4.0mm x 16mm).During a conference call with the rep and reviewing the x-ray, it was clear that the spacer between c6-c7 had subsided.Other information gathered were that the patient smokes a lot, the dr.Had difficulty making the locking tab fully slide over the head of the screw after fully seating the bone screw on the plate.It appears that the locking tab may have been left touching the screw, probably due to the use of a screw angulation that would create this condition with a constrained screw head geometry.

• Brand Name: AZURE ANTERIOR CERVICAL PLATE SYSTEM
• Type of Device: 86-0246
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75069
• 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: 4960422
• MDR Text Key: 23328681
• Report Number: 3008524126-2015-00018
• 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: Followup
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 86-0246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2015
• 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: 64 YR