MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE COROENT SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6980845
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Blood Loss (2597); Patient Problem/Medical Problem (2688)
Date of Event	06/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation nor were x-rays provided to confirm the reported event.Multiple attempts have been made to try and retrieve further event information with no customer response.It is unknown how product was being inserted nor if fluoroscopy was being used.Labeling review: ".Fluoroscopy should be used to verify xlif slides are positioned properly.The inserter is placed with the attached implant between the xlif slides.The implant is advanced across the disc space under a/p fluoroscopy." ".During insertion of the implant, placement is also monitored with nvm5® free run emg.Placement of the implant is dictated by patient anatomy and the spinal pathology that is being treated.".
Event or Problem Description
On (b)(6) 2018 while placing a coroent xl cage, allegedly cage fractured resulting in an unspecified venous injury.No other information has been provided.It is unknown if product was removed from patient nor if procedure continued.

• Brand Name: NUVASIVE COROENT SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7699809
• Report Number: 2031966-2018-00117
• Device Sequence Number: 13702093
• Product Code: MAX
• UDI-Device Identifier: 00887517402998
• UDI-Public: 00887517402998
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6980845
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/18/2018
• 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: Other