MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE RELINE OPEN SYSTEM; STIMULATOR, NERVE

Model Number	10000627
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent an initial fixation procedure.During the procedure, the proximal metal ring of the tap broke off of the instrument and was not retrieved.As a result, the ring was retained in the patient.No further patient impact was reported.No additional information was provided.
Additional Manufacturer Narrative
The complaint device, one (1) reline open tap, was evaluated and the reported device issue was confirmed.The evaluation identified the sleeve on the proximal end of the tap, intended to mate with neuromonitoring components, had been disassembled from the device.Operative notes and/or radiograph images from the initial procedure were not provided for review of usage/technique.A review of the device history records was performed and no discrepancies were found.The root cause of the device failure was determined to be damage caused by excessive force applied to the tap sleeve; however, the nature or source of the excessive force was unable to be determined with the information provided.Labeling review: ".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.".".Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".".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.".".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.

• Brand Name: NUVASIVE RELINE OPEN SYSTEM
• Common Device Name: STIMULATOR, NERVE
• 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: 16288143
• Report Number: 2031966-2023-00013
• Device Sequence Number: 6475367
• Product Code: ETN
• UDI-Device Identifier: 00887517512499
• UDI-Public: 887517512499
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K112709
• 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): 02/02/2023

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: 10000627
• Device Catalogue Number: N/A
• Device Lot Number: NG49866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• 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: 01/08/2023
• Initial Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2015
• 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