MAUDE Adverse Event Report: SEASPINE INC. SKIPJACK EXPANDABLE INTERBODY SYSTEM; IMPLANT, FIXATION DEVICE, SPINAL

Device Problem Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

Radiographs received depicted an interbody backing out of the vertebral body.No product id information, lot number, case report or explants have been received.Dhr review and product investigation cannot be completed, as the device remains in-situ.Revision surgery is planned for early december.Review of labeling notes: 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.The root cause of this event cannot be determined.No conclusions can be drawn.

Event Description

On (b)(6) 2018 patient underwent a one level spinal fusion with skipjack posterior interbody and mariner fixation system.Follow-up exam radiographs showed the skipjack interbody is backing out posteriorly.Patient is asymptomatic.Revision surgery is scheduled for (b)(6) 2018.

• Brand Name: SKIPJACK EXPANDABLE INTERBODY SYSTEM
• Type of Device: IMPLANT, FIXATION DEVICE, SPINAL
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: aaron ; 5770 armada drive; carlsbad, CA 92008 ; 7602165109
• MDR Report Key: 8136113
• MDR Text Key: 129593034
• Report Number: 3012120772-2018-00029
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR