MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE COROENT THORACOL; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 5271308P2

Device Problems Material Fragmentation (1261); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Device Embedded In Tissue or Plaque (3165)

Event Date 02/18/2021

Event Type  Injury  

Manufacturer Narrative

The involved nuvasive implants remain in-situ as no product malfunction was suggested or identified.No radiographs were provided, photographs confirmed metal fragment.The severity and root cause of the hematoma could not be confirmed but is suggestively the result of inadvertent contact from an implant or instrument during the index procedure.The metal fragment found and removed during the revision procedure could not be identified and the origin is unknown.The piece has been retrieved and the patient has recovered well post revision.No additional investigation can be completed.".Potential adverse events and complications.As with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include:.Damage to blood vessels.Tissue reactions including macrophage and foreign body reactions adjacent to implants.".

Event Description

On (b)(6) 2021 a patient underwent an anterior spinal procedure to address stenosis at the l5-s.On (b)(6) 2021 a revision surgery was performed to remove a discovered hematoma at the left pedicle at l5/s.During the revision a metal piece was discovered inside the patient when the surgeon made an incision to remove the hematoma.There was no damage or adverse effects to patient as a result of the recovered fragment and it was retrieved during the revision.

• Brand Name: NUVASIVE COROENT THORACOL
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: dean lucas ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 11465414
• MDR Text Key: 239219274
• Report Number: 2031966-2021-00040
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00887517909176
• UDI-Public: 887517909176
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5271308P2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR