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

Catalog Number	76-0010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot numbers could not be verified as the device was remains with the hospital for evaluation.No further product evaluation could be completed at this time.Patient activity at the time or prior to the event is unknown.The degree of spinal instability is unknown.It is unknown if the patient complied with post-operative care instructions or sustained a fall/impact of some sort.Review of labeling notes: "intraoperative warnings 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.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.Postoperative fracture due to trauma, defects or poor bone stock." the root cause of this event cannot be determined.No conclusions can be drawn.
Event or Problem Description
Deformity correction surgery was performed on an adolescent female ((b)(6) yrs.) with a posterior fixation from t2 - l4 (pso at l2) on (b)(6) 2017.During a routine follow up radiograph noted l3 & l4 locking caps were loose and l3 right screw had shifted, allowing rod to slip from alignment.Patient was asymptomatic.Revision surgery was planned for (b)(6) 2018 to perform a rod cut (using implanted rod) and domino connector to complete.

• Brand Name: DAYTONA PEDICLE SYSTEM
• Common Device Name: THORACOLUMBAR PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad 92008
• MDR Report Key: 7608554
• Report Number: 3012120772-2018-00013
• Device Sequence Number: 19181426
• Product Code: NKB
• UDI-Device Identifier: 10889981079291
• UDI-Public: 10889981079291
• 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
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2018

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: 76-0010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 17 YR