MAUDE Adverse Event Report: NUVASIVE, INC. COROENT INTERLOCK SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number 6791712

Device Problem Fracture (1260)

Patient Problem Neck Pain (2433)

Event Date 08/03/2016

Event Type  malfunction  

Manufacturer Narrative

Radiographs were received and confirmed that the patient had cervical interbody fusions at the c4-c5, c5-c6, and c6-c7 levels using interfixated peek interbody implants.Probable successful fusion at the c4-c5 and c5-c6, with possible fusion at the c6-c7 level.There are two fractured but non-displaced screws at the c6-c7 level; the interbody implant position is satisfactory (no implant migration).Patient reported that her lower back had been doing fine until she fell onto her left side.Patient reported that after her fall she immediately began to experience lower back and left knee pain.Patient indicated there was an increase in pain in her neck within the last few months.The device remains in-situ.Revision surgery is planned for (b)(6) 2016.Root cause is likely due to the patient falling but no further investigation can be completed at this time.Review of labeling notes: "potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation, nonunion or delayed union, fracture of the vertebra." "these devices can break when subjected to the increased load associated with delayed union or nonunion.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant." device remains in-situ.

Event Description

A (b)(6) female underwent an acdf at c4-7 spine levels on (b)(6) 2015.At three-week follow-up, the patient reported reduction in pain/radiculopathy and improved strength.Approximately 17 months postoperatively patient was evaluated for cervical pain and radiculopathy after having fallen as well as lower back and knee pain which necessitated treatment with vicodin.Radiographs confirmed screw fracture at c6-7.A revision surgery is planned for (b)(6) 2016.No patient injury was reported.

• Brand Name: COROENT INTERLOCK SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: stacy gregory ; 7475 lusk blvd; san diego, CA 92121 ; 8587360313
• MDR Report Key: 5904081
• MDR Text Key: 52997764
• Report Number: 2031966-2016-00066
• Device Sequence Number: 1
• Product Code: OVE
• UDI-Device Identifier: 00887517362094
• UDI-Public: 00887517362094
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2016

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: Physician
• Device Model Number: 6791712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 55 YR