MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE PRECEPT SPINAL SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	8801069
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned to nuvasive for evaluation; further, operative notes and/or radiograph images were requested but not provided for review of usage/technique.Information regarding the patient's bone quality was requested but not available.A review of manufacturing records was unable to be performed as the lot information of the product involved in the event was not available.A definitive root cause 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" "use lateral fluoroscopy to properly manage the k-wire during pedicle preparation to ensure proper placement and avoid anterior advancement of the k-wire" "care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient" 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 three (3) level posterior fixation procedure from l2 to l5.During the procedure, upon removal of the kirschner wire (k-wire) from the right l3 vertebrae, it was noted that the distal tip had fractured off and approximately one (1) cm remained within the vertebral body.The fractured portion was unable to be retrieved.No further patient impact was reported.No additional information was provided.

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 16133900
• Report Number: 2031966-2023-00004
• Device Sequence Number: 3326896
• Product Code: LXH
• UDI-Device Identifier: 00887517346964
• UDI-Public: 887517346964
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/10/2023

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: 8801069
• Device Catalogue Number: N/A
• 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: 12/16/2022
• Initial Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 Age: 60 YR
• Patient Sex: Male