MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	10000627
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 during a case, the tip of a reline tap sheered off.All pieces of the fractured tap were retrieved.There was no patient impact as a result of the event.
Additional Manufacturer Narrative
No product was received although a photograph was provided confirming the tip fracture.While a root cause for the issue could not be determined, a review of the information provided suggests excessive or off angled force during use as a probable cause.No additional investigation required.Labeling review: "care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "pre-operative warnings: the method of use for the instruments are to be determined by the user¿s experience and training in surgical procedures.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." "intra-operative warnings: the physician should take precautions against putting undue stress on the spinal area with instruments.Any surgical technique should be carefully followed.It is important that the surgeon exercise extreme caution when working in close proximity to vital organs, nerves, or vessels, and that the force applied to the instrumentation is not excessive, to prevent potential injury to the patient.Over-bending, notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage." device not returned.
Additional Manufacturer Narrative
G3: the initial report contained an incorrect date.The correct date is on (b)(6) 2022.
Event or Problem Description
No additional information is available.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 15113888
• Report Number: 2031966-2022-00132
• Device Sequence Number: 14818957
• Product Code: NKB
• UDI-Device Identifier: 00887517512499
• UDI-Public: 887517512499
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K182974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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: 10000627
• 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: 06/20/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 08/09/2022
• 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