MAUDE Adverse Event Report: NUVASIVE, INCORPORATED COROENT XLR STANDALONE SYSTEM; INTERVERTEBRAL FUSION DEVICEWWITH INTEGRATED FIXATION, LUMBAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Pain (1994); Venipuncture (2129); Blood Loss (2597)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation as no product malfunction has been alleged.There were no radiographs or images provided therefore event cannot be confirmed.Even though root cause cannot be confirmed based on the information provided potential surgical technique and or patient's anatomical condition may have contributed to alleged event.Labeling review: ".Contraindications: contraindications include, but are not limited to: 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.Infrequent operative and postoperative complications known to occur include: damage to blood vessels." ".Warnings, cautions and precautions: potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury." ".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." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".

Event Description

On (b)(6) 2019 patient underwent spinal procedure on l3-s1 levels.On (b)(6) 2019, patient was experiencing left sided abdominal pain and developed hypotension.As per reporter patient was found to be anemic and a ct scan revealed a left retroperitoneal hematoma and active bleeding left retroperitoneum.The patient underwent a revision procedure where exploration of left retroperitoneum with ligation of bleeding vessel was conducted.

• Brand Name: COROENT XLR STANDALONE SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICEWWITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd.; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: virnalisa cobacha ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 10538960
• MDR Text Key: 207146802
• Report Number: 2031966-2020-00183
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00887517151216
• UDI-Public: 887517151216
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• 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: 08/18/2020
• 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
• Treatment: 6951234
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR