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

Model Number 8800000006

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 09/07/2019

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for investigation as product remains in-situ.Radiographs provided confirm the alleged event.Root cause cannot be confirmed at this time.Labeling review: potential adverse events and complications ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." 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." post-operative warnings ".During the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.".

Event Description

Patient underwent a spinal procedure as secondary surgery of an extreme lateral interbody fusion on (b)(6) 2019.It was reported that the set screw of right l5 is loose.As per reporter patient is asymptomatic and it is unknown if patient a revision procedure will be performed.

Event Description

On (b)(6) 2019 a patient underwent a two stage procedure first an extreme lumbar interbody fusion at l1/5 followed by a posterior fixation procedure.On (b)(6) 2019 during follow up the set screw at l1 right was loose left, per surgeons perogative it was left in-situ as is.On (b)(6) 2020 an adjacent segment procedure was performed because of asd on l5/s.(not due to lock screw back off).During surgery, removed screws at l1, l2, and l3.Re-fixation l4, l5 and s (5/stlif).This event was originally reported one two separated complaints ((b)(4)) the second was voided and all the information was combined and investigated into this single report.Additional information review h10.

Manufacturer Narrative

The devices involved in this reported event were returned following removal for an unrelated adjacent segment procedure.The returned devices were examined the complaint was confirmed.Damage identified on the devices indicate insufficient rod reduction obstructing proper lock screw final toque down.No additional investigation required.Labeling review: ".Potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." ".Warnings, cautions and precautions: the implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." ".Final-tighten all lock screws with the counter-torque and torque t-handle.Do not final-tighten through other instruments in the set, as the rod may not be able to normalize to the tulip.Ensure there is enough rod overhang when final tightening, and do not lock down on the conical portion of the rod.Failure to do so may lead to improper lock down of the construct.It may be necessary for the surgeon to add length to the rod, depending upon patient anatomy and desired lordosis.Care should be taken to insure that all components are ideally fixated prior to closure.".

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 9281942
• MDR Text Key: 167985279
• Report Number: 2031966-2019-00251
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K171894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

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: Health Professional
• Device Model Number: 8800000006
• Device Lot Number: JP14507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 10/11/2019
• Supplement Dates FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8826545006
• Patient Age: 63 YR