MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE EXTREME LATERAL LUMBAR IMPLANT INSERTER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6900160
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned to nuvasive for evaluation; the reported event was confirmed by review of a photograph of the fractured inserter.No operative notes and/or radiograph images were provided for review of usage/technique.A review of the device history record was performed and no discrepancies relevant to the reported event were found.A definitive root cause was unable to be determined with the information provided.Labeling review: "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." "care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "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." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial extreme lateral interbody fusion procedure on an unknown date.During the procedure, the distal tip of the implant inserter fractured.The fractured piece was unable to be located and as a result, may have been retained by the patient.It was reported there was no injury attributed to the device; no information on any further patient impact was provided.No further information was available.
Event or Problem Description
Medwatch report # 2031966 - 2023 - 00001 was inadvertently submitted.After a review of the reported event and additional information received, it has been determined that there no indication of an adverse reaction, death or serious injury, or the need for intervention to prevent death or serious injury.Further, death or serious injury is unlikely should this or a similar event recur and unretrieved fragment was left in the patient.No reporting is required.
Additional Manufacturer Narrative
Medwatch report # 2031966 - 2023 - 00001 was inadvertently submitted.After a review of the reported event and additional information received, it has been determined that there no indication of an adverse reaction, death or serious injury, or the need for intervention to prevent death or serious injury.Further, death or serious injury is unlikely should this or a similar event recur and unretrieved fragment was left in the patient.No reporting is required.

• Brand Name: NUVASIVE EXTREME LATERAL LUMBAR IMPLANT INSERTER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 16118212
• Report Number: 2031966-2023-00001
• Device Sequence Number: 5753835
• Product Code: MAX
• UDI-Device Identifier: 00887517383532
• UDI-Public: 887517383532
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K161230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

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: 6900160
• Device Catalogue Number: N/A
• Device Lot Number: 125380-033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2011
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose