MAUDE Adverse Event Report: SEASPINE, INC MARINER PEDICAL SCREW SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	41-1000
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs were received depicted a loose/disassembled lock screw from the right l2 pedicle bone screw.No compatibility studies have been done for the use of a seaspine pedicle screws interacting with competitor's "annex" adjacent level system rods.It is unknown if the rod was properly fixated or can be properly fixated.It is unknown if the malfunction/rotation of the left interbody caused or contributed to the instability of the segment.No product information or explants have not been received and no further product evaluation can be completed.It is unknown if the patient complied with post-op care instructions.There was no report that the patient sustaining an impact/trauma of some sort.The true root cause of this event cannot be determined.No conclusions can be drawn.Review of labeling notes.Labeling, warnings and precautions: bending, disassembly or fracture of implant and components.Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.Postoperative fracture due to trauma, defects or poor bone stock.If the construct contains screws, prior to soft tissue closure, recheck all screws to ensure they are tightened.Failure to do so may cause loosening of the other components.The patient should be advised that implants may bend, break or loosen despite restriction in activity.
Event or Problem Description
Prior to the index surgery, patient had spine fusion and existing construct from l3-l5.On (b)(6) 2017, patient received posterior lumbar interbody fusion (plif) involving two competitor's (globus) expandable interbody implants (left side implant has rotated and collapsed) and competitive (spine wave- annex) adjacent segment rod (l2-l3) attached to two seaspine pedicle bone screws l2.At six weeks during routine follow up, radiographs depicted a disassembly of the right l2 set screw.The patient was asymptomatic.On (b)(6) 2017 patient was revised with competitor's product to stabilize the construct.

• Brand Name: MARINER PEDICAL SCREW SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 6729609
• Report Number: 3012120772-2017-00008
• Device Sequence Number: 19038101
• Product Code: NKB
• UDI-Device Identifier: 10889981065065
• UDI-Public: 10889981065065
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2017

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: Physician
• Device Model Number: 41-1000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 07/20/2017
• 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: 62 YR