MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION EXPLORER TO LORDOSIS EXPANSION; SPACER

Model Number	ET1-272610
Medical Device Problem Codes	Collapse (1099); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The explant was discarded and therefore could not be evaluated.No lot information was provided.No definitive root cause could be determined.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 subsidence of the implant into adjacent bone.
Event or Problem Description
On (b)(6) 2023, a patient underwent spinal surgery consisting of seaspine's explorer to expandable interbody technology.It was reported that during surgery on (b)(6) 2024, the implant was observed to have subsided.Provided x-rays also show the implant had partially migrated out of the disc space.The implant was revised and discarded during the same surgical procedure.The patient is reported to be doing well.No information was provided on the initial reason for the surgery.

• Brand Name: EXPLORER TO LORDOSIS EXPANSION
• Common Device Name: SPACER
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 19616313
• Report Number: 3012120772-2024-00031
• Device Sequence Number: 17691505
• Product Code: MAX
• UDI-Device Identifier: 10889981206444
• UDI-Public: 10889981206444
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K240830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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
• Device Model Number: ET1-272610
• Device Catalogue Number: ET1-272610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown