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

Model Number	91-8490
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the review of the dhr for lot bs18a001f, it was concluded that the product was inspected and accepted for use by the quality control department on 04/27/2017 and met all specified parameters of the receiving inspection report with no associated nonconformance specific to the product issue.Trend review indicates that no adverse trend exists for this fault type.The device was returned and evaluated.The rod holder tip is disassembled from the shaft at the weld.It is unknown under what condition/ forces the device was used during the last case.Since the instrument is a re-usable device, it is unknown how many times exactly the instrument was used.The severity of an inserter that breaks during use causing a significant delay to surgery and requiring additional incision to retrieve broken tip has been identified as serious, per manufacturer's hazard assessment of fixation systems.The root cause of the issue is unknown, but may be the result of handling, misuse or physical damage, which can be the consequence of unintended use or surgical technique.These devices are part of loaner sets that are subjected to handling and multiple uses after distribution into the field.
Event or Problem Description
On (b)(6) 2019, the patient underwent a tlif procedure with the newport system.During the procedure, the distal tip of the rod inserter broke off in-situ.This incident, during rod insertion, required an extended skin incision and additional time to retrieve broken tip.The surgery was successfully completed with a back-up rod inserter and a revision surgery was not planned.No further event information is available.

• Brand Name: NEWPORT PEDICLE SCREW SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 8708861
• Report Number: 3012120772-2019-00016
• Device Sequence Number: 1821476
• Product Code: NKB
• UDI-Device Identifier: 10889981085681
• UDI-Public: 10889981085681
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 91-8490
• Device Lot Number: BS18A001F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1