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

Model Number	8800000006
Medical Device Problem Codes	Unintended Movement (3026); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation nor were radiographs or images provided to confirm the alleged event.No torque device information provided.It is unknown if the patient complied with post-operative physical restrictions.At this time there is insufficient information to determine the root cause.Labeling review: ".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.".".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s).".".Contraindications include but are not limited to: infection, local to the operative site.Signs of local inflammation.Patients with known sensitivity to the materials implanted.Patients who are unwilling to restrict activities or follow medical advice.Patients with inadequate bone stock or quality.".".Care should be taken to insure that all components are ideally fixated prior to closure.".
Event or Problem Description
On (b)(6) 2018, patient underwent a transforaminal lumbar interbody fusion at l5/s1 levels.On (b)(6) 2018 a set screw back out was identified.Patient underwent a revision procedure on (b)(6) 2018 where the set screw was replaced with no reported issues.No patient injury reported.

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 8056922
• Report Number: 2031966-2018-00163
• Device Sequence Number: 1684260
• Product Code: NKB
• UDI-Device Identifier: 00887517344076
• UDI-Public: 00887517344076
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2018

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
• Operator of Device: Health Professional
• Device Model Number: 8800000006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1