MAUDE Adverse Event Report: SEASPINE, INC EXPLORER TO SYSTEM; EXPLORER TO HEIGHT EXPANSION

Model Number	ET1-302808
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The explorer to implant was not returned for investigation as it remains in-situ.However, the implant collapse was confirmed via the provided x-rays.No lot information was provided.Review of labeling: possible adverse events.Bending, disassembly, or fracture of implant and components.
Event or Problem Description
On (b)(6) 2022 a patient underwent spinal surgery consisting of seaspine's explorer to system.At the four-month post-op visit, it was identified that the expandable implant had collapsed.Seaspine was made aware of this event on (b)(6) 2022.There are no plans for revision or removal currently.No further information has been provided about the patient's condition.

• Brand Name: EXPLORER TO SYSTEM
• Common Device Name: EXPLORER TO HEIGHT EXPANSION
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 16230462
• Report Number: 3012120772-2022-00060
• Device Sequence Number: 15196872
• Product Code: MAX
• UDI-Device Identifier: 10889981206505
• UDI-Public: 10889981206505
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: ET1-302808
• Device Catalogue Number: ET1-302808
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown