MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE PRECEPT SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 8826545006

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 08/28/2018

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation as product remains in-situ.No product malfunction reporter.No radiographic images provided therefore alleged malfunction could not be confirmed.A review of the information provided identified that potential anatomical challenges may have caused or contributed to the malplacement.Labeling review: ".Use lateral fluoroscopy to properly manage the k-wire during pedicle preparation to ensure proper placement and avoid anterior advancement of the k-wire." ".The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." ".As with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; pulmonary emboli; loss of sensory and/or motor function; impotence; and permanent pain and/or deformity.Rarely, some complications may be fatal.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, neurological, vascular or visceral injury.".

Event Description

On (b)(6) 2018 a patient underwent a posterior lumbar interbody fusion at l4/5 levels.As per reporter the surgeon noted difficulty determining proper position of screws.On (b)(6) 2018 the surgeon reported the l5 left screw breached into the vertebral canal.No alleged product malfunction.No post-operative adverse symptoms nor revision procedure is planned at this time.

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: george panfili ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 7908131
• MDR Text Key: 121706512
• Report Number: 2031966-2018-00145
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517312358
• UDI-Public: 887517312358
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8826545006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2018
• Initial Date FDA Received: 09/25/2018
• 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): Required Intervention