MAUDE Adverse Event Report: SEASPINE INC. SKIPJACK EXPANDABLE SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number 98-3001

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Spinal Column Injury (2081)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

A device history record (dhr) review could not be performed as a lot number was not provided and the instrument was not returned for evaluation.Radiographs were provided for review, however the dural tear could not be visualized in the radiographs.The reported event of dural tear due to instrument disengaged could not be confirmed.A root cause was unable to be determined at this time.Review of labeling notes: possible adverse events: like other spinal system implants, the following adverse events are possible.This list is not exhaustive: delayed union or nonunion (pseudarthrosis) bending, disassembly or fracture of implant and components pain, discomfort, or abnormal sensations due to the presence of the device pressure on skin where inadequate tissue coverage exists over the implant, with potential extrusion through the skin.Dural leak requiring surgical repair.Cessation of growth of the fused portion of the spine.Subsidence of the implant into adjacent bone.Loss of proper spinal curvature, correction, height and/or reduction.Increased biomechanical stress on adjacent levels.

Event Description

On (b)(6) 2019, the patient underwent spinal surgery with the skipjack expandable system.It was reported that during the procedure, the delivery tower unlocked after being malleted, disengaged from the implant and tore the dura under and against the disc space.It was noted by the reporter that the patient had a fairly collapsed disc space and the surgeon had done quite a bit of malleting to insert the implant.The dura was repaired intraoperatively, however, it was indicated by the reporter that it was unknown if the patient would experience a future csf leak.Surgery was extended approximately 45 minutes and a new interbody was able to be placed.Surgery was successfully completed without additional incident.No further patient or event information is available.

Manufacturer Narrative

H10: investigation results device history records were reviewed, and product was accepted for use by quality control on (b)(6) 2017 with no associated non-conformances related to the product issue.The delivery tower was returned for evaluation and an investigation was completed on (b)(6) 2020.A visual inspection was performed, and the device was observed to be damaged from use.It was noted that the device was bent out of specification and when engaged with a mating implant, the grasping tangs were asymmetrical, and the mating surface was not flush against the implant's engagement pins as intended.Measurements were taken and it was noted that the delivery tower's mating holes may have only been engaged with a portion of the engagement pin versus engaging the entire surface.However, as the inserter is still able to clamp around both intended pins and surfaces, the device was still able to function when the expansion driver is properly seated inside the delivery tower, as specified in the surgical technique.With the expansion driver in place, the exterior housing cannot be removed from the implant without untightening the delivery tower.Functional testing and impaction testing were performed to attempt to replicate the reported failure of the delivery tower disengaging from the implant.Initial testing to replicate the reported failure of the delivery tower disengaging during impaction was not successful.The test was then performed at 3 intervals of device tightening; fully tightened, ¼ turn untightened, and 1 full turn untightened.When fully tightened there was no loosening of the tower to implant engagement.When ¼ turn untightened, some loosening of the delivery tower to implant engagement was observed but the devices remained attached.At 1 full turn untightened, the delivery tower's tangs detached from the implant but the expansion driver inside the tower maintained an inline connection with the implant as the distal tip was connected to the internal hex of the implant.If the driver was not properly seated inside the expansion driver, due to the asymmetry of the delivery tower to implant engagement, the delivery tower may have been able to disengage form the implant with a small amount of force.However, per the surgical technique, the expansion driver is required to be inserted into the delivery tower prior to engagement with the implant and the delivery tower knob should be fully tightened.Per the reporter, the expansion driver was properly inserted into the delivery tower and delivery tower was tightened.The reported failure of delivery tower loosened and disengaged from the implant could not be confirmed as the reported failure could not be replicated.A root cause could not be determined as the reported failure was not confirmed.However, it should be noted that if the expansion driver is not correctly seated inside the implant, and the delivery tower is not fully tightened, the device could disengage.Review of labeling notes: surgical technique: insert the expansion driver through the delivery tower.The expansion driver will ensure that the implant properly aligns with the delivery tower.Verify that the laser etch running length of delivery tower (indicating the top side of the implant) should be in line with the top side of the implant (colored end plate side).The delivery tower engagement holes will close over the implant and securely lock onto the implant by tightening the locking ring on the delivery tower.Prior to implantation, verify that the implant is assembled correctly.Turn the palm torque handle clockwise until max expansion, and then counterclockwise back to initial position.Ensure the implant is completely collapsed and driver is docked into the implant prior to packing with autogenous bone graft.Possible adverse events: like other spinal system implants, the following adverse events are possible.This list is not exhaustive: delayed union or nonunion (pseudarthrosis) 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 pain, discomfort, or abnormal sensations due to the presence of the device pressure on skin where inadequate tissue coverage exists over the implant, with potential extrusion through the skin.Dural leak requiring surgical repair.Increased biomechanical stress on adjacent levels.Improper surgical placement of the implant causing stress shielding of the graft or fusion mass.Intraoperative fissure, fracture, or perforation of the spine.Serious complications associated with any surgery may occur.These include, but are not limited to: wound complications, infection, genitourinary disorders, gastrointestinal disorders, vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; bursitis, hemorrhage, myocardial infarction, paralysis or death.

• Brand Name: SKIPJACK EXPANDABLE SYSTEM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 9387685
• MDR Text Key: 168574466
• Report Number: 3012120772-2019-00032
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 10889981138820
• UDI-Public: 10889981138820
• Combination Product (y/n): N
• PMA/PMN Number: K153786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

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
• Device Operator: Health Professional
• Device Model Number: 98-3001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR