MAUDE Adverse Event Report: NUVASIVE, INCORPORATED EXPANDABLE LUMBAR INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	8083424
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported the cage broke because of excessive torque force being applied while the doctor was trying to rotate the implant to match the disc space.Improper size selection led to extra torque force being required for implant rotation.The root cause of the end plate disruption and subsequent blood loss appears to be the result of an excessive force utilized in an attempt to place an oversized interbody.Surgeon education was completed by field representative at the time of event."warnings, cautions and precautions: 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.Device disposed of at facility.
Event or Problem Description
A cage intraoperatively broke inside a patients disc space.The device was explanted by the surgeon and in the process there was disruption of the end plates at the l5 level which caused bleeding.The bleeding led to a single unit blood transfusion.A 2nd cage was implanted after bleeding was controlled with no issues.Patient is doing fine post-op.

• Brand Name: EXPANDABLE LUMBAR INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; 92121 CA 92121
• MDR Report Key: 11407610
• Report Number: 2031966-2020-00220
• Device Sequence Number: 4503251
• Product Code: MAX
• UDI-Device Identifier: 00887517268112
• UDI-Public: 887517268112
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K130820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/28/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8083424
• 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: 12/02/2020
• Initial Report FDA Received Date: 03/03/2021
• 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: Required Intervention
• Patient Age: 60 YR