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

Model Number	83-0608
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Fall (1848)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant was returned and evaluated by engineering who determined the product met all specifications and functions as designed.Visual inspection: visual inspection and magnification inspection(up to 250x).Bone graft is present in the set screw hex, around the set screw threads and graft windows.Front face of set screw has surface nicks, gouges and scratches.Set screw thread form is not damaged.No signs of rolled threads, flat or smashed threads.No sign of thread peel.All exterior surfaces show no sign of fracture.Test function: upon receipt the driver would not insert into set screw.Bone graft in the hex prevents expansion driver placement.Prep: bone graft was scraped out of the hex feature in order to place a driver.Driver fit into hex.Implant set screw hex was not stripped.The driver could be placed into the hex and fit as intended.Driver could be placed about 2/3 of the way into the hex.(not all bone graft was removed from hex).Expansion driver torque meter was used to expand the implant and measure torque.Specification is 0-15 cn-m.Expansion driver torque averaged around 6-9 cn-m.Easy to turn by hand with slight resistance.Excessive force was not used to expand implant.Implant expanded and collapsed without issues.Test function under load: place 100lb load the top on skipjack implant.Record the torque value for expansion under 100lb load.Test new inventory versus explanted implant.Dhr review: during the review of the dhr for lot cw17l001c, it was concluded that the product was inspected and accepted for use by the quality control department on 11/28/2017 and met all specified parameters of the receiving inspection report with no associated nonconformance specific to the product issue.Review of labeling notes: postoperative warnings: 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.It was reported the patient sustained a fall.The patient's anatomical condition and it's effects on the stability of the implant and/or construct are unknown contributing factors.The root cause is unknown, but the patient's sustained fall may have caused or contributed to the event.
Event or Problem Description
In (b)(6) 2018 patient underwent a ten level (l3 - s1) spinal fusion with skipjack posterior interbody fixation.It was reported patient sustained a fall, but felt no pain after.Follow-up exam showed skipjack had migrated/backed out posteriorly.Revision surgery occurred (b)(6) 2018.Implant was adjusted in the vertebral body.No revision on hardware.It was reported patient felt pain.Follow -up exam showed cage had migrated/ backed out posteriorly for a second time.2nd revision surgery occurred (b)(6) 2018.Implant was removed and replaced with ventura peek interbody.Newport construct was fitted with larger screws for support.In (b)(6) 2018 patient underwent a ten level (l3 - s1) spinal fusion with newport posterior fixation.Surgeon continues to monitor patient.

• Brand Name: SKIPJACK EXPANDABLE INTERBODY SYSTEM
• Common Device Name: IMPLANT, FIXATION DEVICE, SPINAL
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 7912505
• Report Number: 3012120772-2018-00021
• Device Sequence Number: 19297610
• Product Code: JDN
• UDI-Device Identifier: 10889981139889
• UDI-Public: 10889981139889
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K153786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2018

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: Health Professional
• Device Model Number: 83-0608
• Device Lot Number: CX17L001C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 50 YR