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

Model Number	41-1000
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The screws were not returned for investigation and lot numbers were not available to review device history records.However, radiographs were provided, which showed locking caps disengaged and screws backed out at s1.The reported allegation of screws backing out post-operatively was confirmed.A root cause was unable to be determined as the screws were not able to be physically evaluated, there were no reported issues with surgical technique and it is unknown if the patient complied with post-operative warnings, all of which can contribute to post-operative loosening.Review of labeling notes: intra-operative warnings: if the system/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.Postoperative warnings: the patient should be advised to limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation.The patient should be advised that implants may bend, break or loosen despite restriction in activity.Possible adverse events: 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.It is unknown if the patient sustained a fall.The patient's anatomical condition and the effects on the stability of the implant and/or construct may be unknown contributing factors.
Event or Problem Description
On (b)(6) 2018, the patient underwent posterior spinal fusion from levels t10-s1 with deformity correction using the mariner pedicle screw system.The patient had subsequent follow-up appointments and radiographs were taken on (b)(6) 2018 and (b)(6) 2018.It was reported that instrumentation failure occurred at the l4-l5 and l5-s1 levels, as the mariner screws had disengaged.Revision surgery was performed on (b)(6) 2018 and included anterior lumbar interbody fusion of l5-s1, posterior spinal fusion of l4-5 and l5-s1, lumbar re-instrumentation of l4-5 and l5-s1 and a caudal extension of fixation to the pelvis.Additional radiographs were taken post-surgery on (b)(6) 2018 to monitor the patient's condition.At the time of contact, the patient was reported to be doing fine.No further patient information is available.

• 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: 8375949
• Report Number: 3012120772-2019-00004
• Device Sequence Number: 13786117
• Product Code: NKB
• UDI-Device Identifier: 10889981065065
• UDI-Public: 10889981065065
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 41-1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/27/2019
• 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: 71 YR