MAUDE Adverse Event Report: NUVASIVE, INCORPORATED ARCHON ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8780213
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	04/12/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
No product malfunction suggested and no device was returned.Provide radiographs confirmed the arterial damage.Review of the reported event identified an inadvertent screw misplacement that lacerated the patient artery requiring medical intervention including four units of blood and being said by the surgeon to result in the patients death.No additional investigation required.Label review ".Potential adverse events and complications.As with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications known to occur include.Damage to blood vessels.Rarely, some complications may be fatal." ".Potential risks identified with the use of this system, which may require additional surgery, include.Neurological, vascular or visceral injury.Death." ".Warnings, cautions and precautions.The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." ".The nuvasive archon anterior cervical plate system is available in a variety of sizes to insure proper sizing of implanted components.Correct selection of the implant is extremely important.Proper selection can minimize risks." ".Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." device left in-situ.
Event or Problem Description
A patient underwent a cervical procedure on c3/c5.Post screw insertion, the surgeon observed significant bleeding from one of the screw holes.He removed all implants to gain control of the bleeding.It was estimated a possible 4 units of blood were given in the case with more being provided post op.The bleeding was the result of a vertebral artery injury.Once in control of the bleeding the implants were reinstalled and the surgery was completed.On (b)(6) 2021, we were notified the patient had passed away.

• Brand Name: ARCHON ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 11776219
• Report Number: 2031966-2021-00063
• Device Sequence Number: 19617490
• Product Code: KWQ
• UDI-Device Identifier: 00887517199850
• UDI-Public: 887517199850
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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: 8780213
• 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: 04/18/2021
• Initial Report FDA Received Date: 05/05/2021
• 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: Death
• Patient Age: 77 YR