MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE® PRECEPT¿ SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 8827545006

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Vertebral Fracture (4520)

Event Date 03/30/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a patient underwent a transforaminal lumbar interbody fusion procedure from l4-s1 and the procedure was completed without issue.On (b)(6) 2022, a revision occurred as the patient experienced a vertebral fracture at l4.During the revision it was discovered that the l4 screw had become loose due to the bone fracture and it was also observed a screw was loose at the l5.Balloon kyphoplasty occurred to address the fracture, the loose screws were replaced and the construct was extended to l2-s1.

Manufacturer Narrative

No product was received as the involved device was not returned for evaluation and no radiographs were provided confirming alleged incident.No patient falls or accident could be confirmed however no information regarding the patients post op activity levels could be provided.The root cause of the vertebral fracture and l4 screw loosening is unknown but may be the result implant selection, excessive post operative physical activity or bone quality.No additional investigation can be completed.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: fracture of the vertebra." "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." "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.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques.".

Manufacturer Narrative

Corrections.

Event Description

A list of corrected data is found in section h10.

• Brand Name: NUVASIVE® PRECEPT¿ SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 14136724
• MDR Text Key: 289451316
• Report Number: 2031966-2022-00075
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517103499
• UDI-Public: 887517103499
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8827545006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2022
• 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
• Patient Age: 77 YR
• Patient Sex: Male