MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-12 for NUVASIVE COROENT SYSTEM manufactured by Nuvasive Inc..
[188117503]
No product has been returned for evaluation as no product malfunction was alleged. Product was re-positioned and left in-situ. No radiographs or images provided to confirm the alleged event. Review of the reported event as well as surgeons comments confirm the root cause may be related to unintended use. Labeling review: "... 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.. " "... Pre-operative warnings care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient... " "... Potential adverse events and complications as with any major surgical procedures, there are risks involved in spinal/orthopedic surgery. Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; pulmonary emboli; loss of sensory and/or motor function; pleural effusions, hemothorax, chylothorax, pneumothorax, subcutaneous emphysema, need for chest tube insertion, intercostal neuralgia, rib fracture, diaphragm injury; atelectasis; impotence; permanent pain and/or deformity. Rarely, some complications may be fatal. The treatment of multilevel degenerative scoliosis may be associated with a lower interbody fusion rate compared to one and two-level interbody fusions. 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, nonunion or delayed union, fracture of the vertebra, neurological, vascular or visceral injury, metal sensitivity or allergic, reaction to a foreign body, infection, decrease in bone density due to stress shielding, pain, discomfort or abnormal sensations due to the presence of the device, nerve damage due to surgical trauma... "
Patient Sequence No: 1, Text Type: N, H10
[188117504]
A patient underwent a transforaminal lumbar interbody fusion at l5/s1 on (b)(6) 2020. It was reported that the cage popped out to anterior side of vertebral body. The physician utilized the removal tool to retrieve the cage and re located it to a suitable location.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031966-2020-00037 |
| MDR Report Key | 9826538 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GEORGE PANFILI |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer G1 | NUVASIVE |
| Manufacturer Street | 7475 LUSK BLVD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUVASIVE COROENT SYSTEM |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR |
| Product Code | MAX |
| Date Received | 2020-03-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUVASIVE INC. |
| Manufacturer Address | 7475 LUSK BLVD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-12 |