MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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

Patient Problems Fall (1848); Vertebral Fracture (4520)

Event Date 01/24/2024

Event Type  Injury  

Event Description

On (b)(6) 2023 a patient underwent a posterior fixation procedure from t10 to s2.The surgery was completed with out issue.On an unknown date, it was reported that the patient experienced a fall resulting in a burst fracture at t10.A revision procedure occurred on (b)(6) 2024 where the two screws at t10 were found to be loosened as a result of the fall.The loose screws were replaced and the construct was extended to t7.It is noted that the patient had poor bone quality.

Manufacturer Narrative

No product malfunction was alleged therefore no product was returned for evaluation.Photograph provided is blurry and unclear therefore the complaint cannot be confirmed.Review of the reported information clearly stated that the patient experienced a fall resulting in the burst fracture and screw loosening.It was also noted the patient had poor bone quality.The root cause is considered the result of the noted patient related issues - the fall and bone quality.No additional investigation necessary.Labeling review: "contraindications contraindications include, but are not limited to:.5.Patients with inadequate bone stock or quality.6.Patients with physical or medical conditions that would prohibit beneficial surgical outcome." "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 components.Fracture of the vertebra." "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." 9401879-en p-12/2018 h3 other text : device not returned.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 18712135
• MDR Text Key: 335477218
• Report Number: 2031966-2024-00052
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K223181
• 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
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2024
• 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: 79 YR
• Patient Sex: Female