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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Venipuncture (2129); Blood Loss (2597)
Date of Event	11/08/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: INTERVERTEBRAL FUSION DEVICEWWITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd.; san diego CA 92121
• MDR Report Key: 10538960
• Report Number: 2031966-2020-00183
• Device Sequence Number: 304676
• Product Code: OVD
• UDI-Device Identifier: 00887517151216
• UDI-Public: 887517151216
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K100043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2020

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
• 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: 08/18/2020
• Initial Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6951234
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 70 YR