MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE, INCORPORATED; STIMULATOR, NERVE

Model Number	1023501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Urinary Retention (2119)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was received for evaluation as no alleged product malfunction was made.No radiographs or photographs were provided therefore alleged event could not be confirmed.Review of procedure notes provided outline the ureteral injury took place as a result of possible inter-operative difficulty.Labeling review: ".Access: care should be taken to avoid expanding the blades to the mid-vertebral body or beyond to minimize psoas trauma and reduce the risk of segmental vessel injury." ".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; and permanent pain and/or deformity." ".Potential adverse events and complications: 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.".
Event or Problem Description
On unknown date, a patient underwent the first of a two-part procedure an extreme lateral interbody fusion at l1/5 levels via a right sided transpsoas retroperitoneal approach, where the ureteral was reported as injured.Seven days post procedure the second half of the procedure, a posterior fixation from t12 to ilium was completed with no additional issues reported.During follow-up, eight days post-operative, discharge was effluxed from the wound and a computed tomography revealed abnormal accumulation fluid around the right kidney.16 days later, an end to end ureteroureterostomy was successfully performed with no post-op symptoms.

• Brand Name: NUVASIVE, INCORPORATED
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 9556094
• Report Number: 2031966-2020-00002
• Device Sequence Number: 11511554
• Product Code: ETN
• UDI-Device Identifier: 00887517118905
• UDI-Public: 887517118905
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1023501
• 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: 12/12/2019
• Initial Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR