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

Model Number	82-2210
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	10/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient was revised on (b)(6) 2016.Patient current status is unknown.The dhr was reviewed with no nonconformities.Device was returned with no visible damage and met dimensional specifications.Radiographs/mri dated (b)(6) 2016 confirm the migration.There is no evidence that the implant collapsed or malfunctioned.No bony engrowth noted which is expected for a short implant duration.It is unknown what caused the implant to migrate.It is unknown if the patient followed post-operative instructions or sustained a fall that may have contributed to the implants migration.No conclusion can be drawn.Labeling warnings and precautions: the patient is expected to follow the detailed instructions, limitations, and warnings from the surgeon.Detailed instructions on the use and limitations of the device should be given to the patient.If partial weight-bearing is recommended or required prior to firm bony union, the patient must be warned that loosening or breakage of the implant are complications which can occur as a result of excessive or early weight-bearing or excessive muscular activity.The risk of bending, loosening, or breakage of an internal fixation device during postoperative rehabilitation may be increased if the patient is active, or if the patient is debilitated, demented, or otherwise unable to use crutches or other such weight supporting devices.The patient should be warned to avoid falls or sudden jolts in spinal position.Pain, discomfort, or abnormal sensations due to the presence of the device.Loosening and/or dislocation of implant components.
Event or Problem Description
On (b)(6) 2016 (b)(6) male patient had an expandable implant placed at l5-s1 in a two level construct.During their routine six week follow up visit the patient complained of severe leg pain.On (b)(6) 2016 radiographs confirmed the device had migrated.On (b)(6) 2016 patient was revised with an additional expandable cage.

• Brand Name: EXPANDABLE INTERBODY
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT LUMBAR
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 6239512
• Report Number: 3012120772-2017-00001
• Device Sequence Number: 16321229
• Product Code: MAX
• UDI-Device Identifier: 10889981049225
• UDI-Public: 10889981049225
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K133418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2017

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 Model Number: 82-2210
• Device Lot Number: AU4680202B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2016
• Initial Report FDA Received Date: 01/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 91