MAUDE Adverse Event Report: SEASPINE INC. LATERAL FUSION DEVICE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	31-23-1245-12
Medical Device Problem Codes	Mechanical Problem (1384); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Radiograph were received confirming the event.Radiograph also confirmed no fixation was present at that level.Additionally it was reported that the possible causes of this event may be the result of the patient's anatomy and the corresponding tension on the contra-lateral side resulted in the migration of the cage.Review of labeling notes: ".Ibd is intended for use with supplemental fixation that is in addition to the integrated buttress spin plate, such as a pedicle screw system or anterior plate." lot numbers could not be verified as the device was discarded by the user facility.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.The root cause of this reported event has not been determined.
Event or Problem Description
Patient had previous fusion surgery from s1-l4 with posterior fixation; date unknown.On (b)(6) 2018, patient underwent lateral interbody fusion surgery on l3-l4 with no fixation at l3-l4.On (b)(6) 2018 it was discovered that the interbody had migrated laterally outside the vertebral body at l3-l4.Revision surgery was performed to remove and replace the device.Posterior fixation was added.

• Brand Name: LATERAL FUSION DEVICE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SEASPINE INC.; carlsbad CA 92008
• MDR Report Key: 7298106
• Report Number: 3012120772-2018-00001
• Device Sequence Number: 13692423
• Product Code: MAX
• UDI-Device Identifier: 10889981046699
• UDI-Public: 10889981046699
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112986
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2018

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?: No
• Operator of Device: Physician
• Device Catalogue Number: 31-23-1245-12
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR