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

Model Number	5271308P2
Medical Device Problem Codes	Material Fragmentation (1261); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 11465414
• Report Number: 2031966-2021-00040
• Device Sequence Number: 17024807
• Product Code: MAX
• UDI-Device Identifier: 00887517909176
• UDI-Public: 887517909176
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/11/2021

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: 5271308P2
• 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: 02/18/2021
• Initial Report FDA Received Date: 03/11/2021
• 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