MAUDE Adverse Event Report: NUVASIVE NUVASIVE COHERE THORACOLUMBAR INTERBODY SYSTEM; IINTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	8151050P2
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation as there was no product malfunction alleged.No radiographs have been provided to confirm the alleged event.Even though root cause cannot be confirmed, a review of the reported event indicated event may be related to surgical technique.The surgeon switched back to the former product without incident and the patient was reported to have recovered.Labeling review: ".Warnings carefully inspect product packaging and all device components for damage or defects prior to use.Do not use any device if it appears defective, damaged or otherwise compromised." ".Precautions correct selection of cohere cervical interbody fusion device components is extremely important.Carefully select the appropriate device size based on the needs of each individual patient." ".Potential adverse effects nerve damage due to surgical trauma or presence of the device.".
Event or Problem Description
As per reporter implant advanced anterior while still connected to the inserter and injured the anterior longitudinal ligament.The cage was reportedly removed.

• Brand Name: NUVASIVE COHERE THORACOLUMBAR INTERBODY SYSTEM
• Common Device Name: IINTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 10204384
• Report Number: 2031966-2020-00134
• Device Sequence Number: 1019972
• Product Code: MAX
• UDI-Device Identifier: 00887517982261
• UDI-Public: 887517982261
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K181860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2020

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: 8151050P2
• 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: 05/29/2020
• Initial Report FDA Received Date: 06/27/2020
• 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: Other