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

Model 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	06/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was received and reviewed by system engineer.8 mariner 6.5 shanks, 8 set screw, 8 polyaxial screw heads, and 2 rods were returned for review.All heads were assembled onto shanks, except for the implant that was reportedly detached post-operatively.Functional testing was conducted to understand the head pull off strength of the mariner head when partial thread engagement is presented.In multiple tests with set screws from multiple lots the damage appears to be identical to the set screw that detached in this incident.Based on the fatigue testing results, the surgeon should consider the levels of implantation, patient weight, patient activity level,other patient conditions.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.The root cause is likely that the polyaxial head was not fully threaded onto the shank at time of surgical close, which lead to the detachment observed post-operatively.
Event or Problem Description
Initial spinal construct surgery, covering levels t10 - l2, was performed in (b)(6) of 2018 post-operative follow-up determined a screw head at l2 pedicle had detached from the bone screw.Revision surgery occurred on (b)(6) 2018.Revision surgery consisted of a total removal of hardware and replaced with competitor construct.

• 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: 8031232
• Report Number: 3012120772-2018-00026
• Device Sequence Number: 11109219
• Product Code: NKB
• UDI-Device Identifier: 10889981065065
• UDI-Public: 10889981065065
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2017

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: Health Professional
• Device Model Number: 41-1000
• Device Lot Number: AW80812B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR