MAUDE Adverse Event Report: SEASPINE INC. SEASPINE MARINER PEDICLE SCREW SYSTEM; SOLID SCREW 7.50 X 40MM

Model Number	41-7540-1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No implants were made available for analysis as the screw was discarded by the facility and the set screws remain in-situ.Additionally, no x-rays were made available for review.Review of labeling: possible adverse events pain, discomfort, or abnormal sensations due to the presence of the device.Bending, disassembly or fracture of implant and components.Improper surgical placement of the implant causing stress shielding of the graft or fusion mass.Reference: 3012120772-2020-00069.
Event or Problem Description
The patient underwent spinal surgery on (b)(6) 2020 consisting of seaspine's mariner pedicle screw system.A revision surgery was performed on (b)(6) 2020 to correct the trajectory of an s1 screw (mfg ref (b)(4): 41-7540-1) that was reported to have been too lateral.During the revision surgery, it was discovered that the set screws at s1/s2 were loose (mfg ref (b)(4): 41-1010).The surgeon completed the revision surgery by replacing and redirecting the s1 screw as planned, reinserting the set screw, and tightening the remaining set screws.

• Brand Name: SEASPINE MARINER PEDICLE SCREW SYSTEM
• Common Device Name: SOLID SCREW 7.50 X 40MM
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad, ca
• MDR Report Key: 10491218
• Report Number: 3012120772-2020-00070
• Device Sequence Number: 3120381
• Product Code: NKB
• UDI-Device Identifier: 10889981068950
• UDI-Public: 10889981068950
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 41-7540-1
• Device Catalogue Number: 41-7540-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR