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

Model Number	69-5530
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fractured screws were not returned for investigation as they currently remain in-situ.Lot numbers were not available to review device history records however, all screws are required to pass a final inspection that includes functional and dimensional testing, and material certification prior to distribution.A radiograph was provided, which showed the pedicle screw fractured at t12.The reported allegation of fractured screw 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 fracture/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) 2017, the patient underwent posterior spinal fixation using the daytona pedicle screw system.During subsequent patient follow-up an x-ray was taken, and it was observed that a fracture of the pedicle screws had occurred at t12, two years post-operation.Additionally, it was indicated that pseudarthrosis was visible from the x-ray.At the time of contact, revision surgery had not yet been scheduled, but the surgeon reported that they planned to revise.No additional patient information is available.

• Brand Name: DAYTONA PEDICLE SCREW SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 8441327
• Report Number: 3012120772-2019-00010
• Device Sequence Number: 1019260
• Product Code: NKB
• UDI-Device Identifier: 10889981008642
• UDI-Public: 10889981008642
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2019

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: 69-5530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1