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

Catalog Number	41-1000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs confirming the event were received.No revision is planned at this time and the patient remains asymptomatic.Dhr review and product investigation cannot be completed as the product has not been returned because the device remains in-situ.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.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." patient was being treated for compression fractures and focal kyphosis.The patient's anatomical condition and its affects on the stability of the construct are unknown contributing factors.The root cause of this event cannot be determined.No conclusions can be drawn.
Event or Problem Description
Initial surgery on (b)(6) 2016 involved bilateral posterior fixation.The three level construct in the thoracic region was to treat compression fracture and focal kyphosis.Unrelated to the index surgery, additional surgery occurred again in (b)(6) 2016 to treat additional fractures above the (b)(6) 2016 construct.Intra-operative images did not show set screw loose.Post-op x-rays also did not show set screws loose.Follow-up exam and radiographs in (b)(6) 2017 showed lock screw loosening and disassociating from cephalad end of construct.Patient is asymptomatic.No revision is planned at this time.

• Brand Name: MARINER PEDICLE SCREW SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 6830562
• Report Number: 3012120772-2017-00009
• Device Sequence Number: 59705
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2017

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 Catalogue Number: 41-1000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1