MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MARINER PEDICLE SCREW SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	41-6540-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Seaspine was notified of a bilateral screw failure of solid mariner shanks.The included x-ray appeared to show that the screw fractured at the neck of the device index surgery was on (b)(6) 2022, and the fracture was discovered in a post op scan (b)(6) 2022.
Additional Manufacturer Narrative
Seaspine was notified of a bilateral screw failure of solid mariner shanks.The included x-ray appeared to show that the screw fractured at the neck of the device index surgery was on (b)(6) 2022, and the fracture was discovered in a post op scan (b)(6) 2022.Follow ups for further information have been extended.There was no additional details provided by the reporter or the facility.Review of labeling: possible adverse events: like other spinal system implants, the following adverse events are possible.This list is not exhaustive: delayed union or nonunion (pseudarthrosis); 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; pain, discomfort, or abnormal sensations due to the presence of the device; pressure on skin where inadequate tissue coverage exists over the implant, with potential extrusion through the skin; dural leak requiring surgical repair; cessation of growth of the fused portion of the spine; subsidence of the implant into adjacent bone; loss of proper spinal curvature, correction, height and/or reduction; increased biomechanical stress on adjacent levels; improper surgical placement of the implant causing stress shielding of the graft or fusion mass; intraoperative fissure, fracture, or perforation of the spine; postoperative fracture due to trauma, defects, or poor bone stock.Serious complications associated with any surgery may occur.These include, but are not limited to: wound complications, infection, genitourinary disorders, gastrointestinal disorders, respiratory disorders; cardiovascular disorders, including myocardial infarction (heart attack) or arrythmias; neurologic injuries resulting in weakness, paralysis, numbness, tingling, or pain; vascular (blood vessel) injuries, hemorrhage (bleeding); thrombosis (blood clots) leading to deep venous thrombosis or pulmonary embolism, or death.
Event or Problem Description
This supplemental is being filed to include the udi number that was available, but not included in the initial report.Seaspine was notified of a bilateral screw failure of solid mariner shanks.The included x-ray appeared to show that the screw fractured at the neck of the device index surgery was on (b)(6) 2022, and the fracture was discovered in a post op scan (b)(6) 2022.
Additional Manufacturer Narrative
Seaspine was notified of a bilateral screw failure of solid mariner shanks.The included x-ray appeared to show that the screw fractured at the neck of the device.Index surgery was on (b)(6) 2022, and the fracture was discovered in a post op scan (b)(6) 2022.Follow ups for further information have been extended.There was no additional details provided by teh reporter or the facility.Review of labeling: possible adverse events like other spinal system implants, the following adverse events are possible.This list is not exhaustive: delayed union or nonunion (pseudarthrosis) 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, discomfort, or abnormal sensations due to the presence of the device pressure on skin where inadequate tissue coverage exists over the implant, with potential extrusion through the skin dural leak requiring surgical repair cessation of growth of the fused portion of the spine subsidence of the implant into adjacent bone loss of proper spinal curvature, correction, height and/or reduction increased biomechanical stress on adjacent levels improper surgical placement of the implant causing stress shielding of the graft or fusion mass intraoperative fissure, fracture, or perforation of the spine postoperative fracture due to trauma, defects, or poor bone stock serious complications associated with any surgery may occur.These include, but are not limited to: wound complications, infection, genitourinary disorders, gastrointestinal disorders, respiratory disorders; cardiovascular disorders, including myocardial infarction (heart attack) or arrythmias; neurologic injuries resulting in weakness, paralysis, numbness, tingling, or pain; vascular (blood vessel) injuries, hemorrhage (bleeding); thrombosis (blood clots) leading to deep venous thrombosis or pulmonary embolism, or death.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: taara maharaj ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165150
• MDR Report Key: 15514463
• Report Number: 3012120772-2022-00032
• Device Sequence Number: 20297487
• Product Code: NKB
• UDI-Device Identifier: 10889981068219
• UDI-Public: 10889981068219
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 41-6540-1
• Device Catalogue Number: 41-6540-1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 08/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown