MAUDE Adverse Event Report: SEASPINE INC. NEWPORT SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	91-8206
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the review of the dhr for lot mw04927a, it was concluded that the product was inspected and accepted for use by the quality control department on 10/26/2009 and met all specified parameters of the receiving inspection report with no associated nonconformance specific to the product issue.The device was visually inspected and confirmed to have experienced fracturing at the distal tip.The root cause was unable to be determined, however, could be the result of excessive force within the surgical setting, repetitive use, or consequential handling outside the surgical setting.The device is part of loaner sets that are subject to handling and multiple sterilization cycles after distribution into the field.This lot was released into the field in 2009, which indicates a significant period of use.
Event or Problem Description
On (b)(6) 2018, the patient underwent a one level tlif procedure with the newport system.During the procedure, a piece of the distal tip of the large dilator broke off in-situ.The incision was explored thoroughly but the broken piece was unable to be located.It was indicated that the broken piece could have fallen off the field, been suctioned up or fragments could have remained within the patient's soft tissue.The surgery was successfully completed with a back-up dilator and a revision surgery was not planned.No further event information is available.

• Brand Name: NEWPORT SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 8241917
• Report Number: 3012120772-2019-00001
• Device Sequence Number: 14023167
• Product Code: NKB
• UDI-Device Identifier: 10889981083120
• UDI-Public: 10889981083120
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K083089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2019

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: 91-8206
• Device Lot Number: MW04927A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1