MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE HELIX MINI ACP SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	7741115
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 a patient underwent a spinal procedure on unknown levels of the spine.On (b)(6) 2021 it was discovered that during a routine follow up that an implanted screw advanced through the canted coil locking mechanism of an implanted plate and into the vertebral body.The patient in asymptomatic and no revision is planned.
Additional Manufacturer Narrative
No product was returned for evaluation as the device currently remains in-situ but a lateral radiograph was provided confirming the device failure.The patient is currently asymptomatic and no revision is planned.The patients post op activity levels or whether the patient experienced a fall is unknown.A root cannot be determined at this time however a review of the event report and radiograph suggest screw placement was off centered resulting in plate contact screw damage as a suggested cause of contributor.No additional investigation required."potential adverse events and complications 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 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." " warnings, cautions and precautions: correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants.The physician/ surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc, which may impact the performance of the system." "all components should be final tightened per the specifications in the surgical technique.Implants should not be tightened past the locking point, as damage to the implant may occur." "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.".

• Brand Name: NUVASIVE HELIX MINI ACP SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 12522561
• Report Number: 2031966-2021-00131
• Device Sequence Number: 19841463
• Product Code: KWQ
• UDI-Device Identifier: 00887517096784
• UDI-Public: 887517096784
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K073275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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: 7741115
• 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: 09/09/2021
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1