MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE CAMBER LAMINOPLASTY SYSTEM; ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Model Number	7650505P
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned as it remains in-situ; however, the thee (3) lateral radiographs provided were able to confirm the reported event.The patients post-operative activity levels are unknown.Based on the information obtained, the root cause of the event is unknown, though may be a result of hole preparation, implant selection and placement, and post-operative activity levels may be a cause or contributor.No additional investigation can be performed.Label review "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)¿" warnings, cautions and precautions - the subject device is intended for use only as indicated.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.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.Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone.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." device remains in-situ.
Event or Problem Description
It was reported that a patient underwent a three (3) level procedure at c4/c6 on (b)(6)2022.During a subsequent appointment on (b)(6) 2022, it was identified that the a screw had migrated and was outside of the plate.It was reported that the migration had stopped and that the patient was under observation.The patient was not reported to be experiencing any pain or adverse consequences as a result of the device migration.No plans for a revision surgery have been reported.

• Brand Name: NUVASIVE CAMBER LAMINOPLASTY SYSTEM
• Common Device Name: ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd.; san diego CA 92121
• Manufacturer Contact: geoffrey gannon ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 15801606
• Report Number: 2031966-2022-00255
• Device Sequence Number: 7015574
• Product Code: NQW
• UDI-Device Identifier: 00887517995605
• UDI-Public: 887517995605
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2022

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: 7650505P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CAMBER PLATE
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 47 KG