MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE VUEPOINT II OCT SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	8977105
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned and no images were provided therefore the complaint cannot be confirmed.Despite multiple attempts to gain more information about device lot age and user injury no additional information was received and no root cause can be determined.Should the device be returned a follow up report will be sent.Labeling review: "pre-operative warnings: the instruments should be carefully examined prior to use for functionality, excessive wear, or damage.A damaged instrument should not be used as this may increase the risk of malfunction and potential patient injury.Care should be used during surgical procedures to prevent damage to the devices and injury to the patient." "complications to the hospital staff may include, but are not limited to: cutting of skin.Physical injury that may result from the disassembly of multi-component instruments occurring during surgery.Injury that may result from instrument breakage, slippage, misuse, or mishandling." "residual risks and potential side effects: residual risks to surgical staff associated with use of general surgical systems are: lacerations, cuts, or abrasions, including due to instrument breakage, slippage, misuse, or mishandling.Physical injury that may result from the disassembly of multi-component instruments occurring during surgery.".
Event or Problem Description
On (b)(6), 2023 during a spinal procedure a rod cutter broke while cutting a 3.5 mm titanium rod.A piece of the instrument flew into the face of one of the staff assisting in the surgery and caused injury.

• Brand Name: NUVASIVE VUEPOINT II OCT SYSTEM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 16593525
• Report Number: 2031966-2023-00049
• Device Sequence Number: 16870607
• Product Code: NKG
• UDI-Device Identifier: 00887517063045
• UDI-Public: 887517063045
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K180198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8977105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose