MAUDE Adverse Event Report: NUVASIVE, INC NUVASIVE SPHERX SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 7782004

Device Problems Detachment Of Device Component (1104); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 05/17/2017

Event Type  malfunction  

Manufacturer Narrative

A radiograph was received which confirmed the event.No product has returned for evaluation therefore root cause cannot be identified.Labeling review potential adverse events and complications "potential risk identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation." patient education: "preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed.".

Event Description

On (b)(6) 2017, a patient underwent a lumbar fusion procedure at l5.Postoperatively, it was reported a tulip, rod and lock screw disengaged from the shank.Revision surgery was performed on (b)(6) 2017 no patient injury reported.

• Brand Name: NUVASIVE SPHERX SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): NUVASIVE, INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: kim mccaleb ; 7475 lusk blvd; san diego, CA 92121 ; 8589091980
• MDR Report Key: 6637395
• MDR Text Key: 77467176
• Report Number: 2031966-2017-00066
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517121738
• UDI-Public: 00887517121738
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090981
• 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: 06/13/2017

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: No Information
• Device Model Number: 7782004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2017
• Initial Date FDA Received: 06/13/2017
• 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