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

Model Number	5450065
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an l3 to l4 extreme lumbar interbody fusion procedure on 02 august 2022 the surgeon noticed that the tip of their driver fractured and was lodged into the head of an implanted screw and could not be retrieved.The surgeon opted not to attempt a retrieval of the fragment as they thought it would not be possible.No patient injury was reported as a result of the event.
Additional Manufacturer Narrative
No device was returned for evaluation; however, two (2) anteroposterior radiographs provided, three (3) photographs of the screwdriver, and an onsite representative were able to confirm the reported tip fracture.Examination of the photographs confirmed approximately 5 mm of the tip had fractured and the residual fingers are slightly deformed, suggestive of excessive force.Based on the information obtained, the root cause of the reported tip fracture is unknown; however, excessive or off-angled force may be a likely cause or potential contributing factor.No additional investigation can be completed at this time.Labeling review: "pre-operative warnings.¿implants and instruments should be protected during storage and from corrosive environments.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "pre-operative warnings.The instruments should be treated as any precision instrument and should be carefully placed on trays, cleaned after each use, and stored, according to generally accepted hospital methods and practices.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." "intra-operative warnings.The physical characteristics required for many instruments do not permit them to be manufactured from implantable materials.If any broken fragments of instruments remain in the body of a patient, they could cause allergic reactions or infections.If an instrument breaks in surgery and fragments go into the patient, these pieces should be removed prior to closure and should not be implanted." device not returned to manufacturer.

• Brand Name: NUVASIVE THORACOLUMBAR INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 15306569
• Report Number: 2031966-2022-00162
• Device Sequence Number: 6314390
• Product Code: MAX
• UDI-Device Identifier: 00887517247988
• UDI-Public: 887517247988
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K203714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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: 5450065
• Device Lot Number: TU6962
• 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: 08/04/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2019
• 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: Female