MAUDE Adverse Event Report: SEASPINE, INC EXPLORER TO SYSTEM; INTERVERTEBRAL FUSION DEVICE

Model Number	ET1-383210
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A patient underwent spinal surgery consisting of seaspine' s explorer to system.The index surgery took place on (b)(6) 2023.On 19 june 2023 seaspine became aware that an et1-383210 height expansion, 9mm x 32mm x 10-14mm, 8 deg fractured during a case and was left in place in the patient.According to the customer this occurred when the implant was impacted and then rotated into place at l4/5.While rotating it fractured and was left in place.The surgery was completed, and the broken cage left in place.No parts are available for inspection.The hospital and surgeon are not expecting a response.While the initial report the an intra-operative fracture occurred was received on 07jun2023, information was received 19jun2023 regarding the status of the implant and that it was not retreived, indicating that this report was reportable.No root cause was identified as the device was left in situ upon fracture.There is no device for evaluation, and the x-ray images provided are not sufficient to determine the root cause.Review of labeling: possible adverse events bending, disassembly, or fracture of implant and components.
Event or Problem Description
A patient underwent spinal surgery consisting of seaspine' s explorer to system.The index surgery took place on (b)(6) 2023.On 19 june 2023 seaspine became aware that an et1-383210 height expansion, 9mm x 32mm x 10-14mm, 8 deg fractured during a case and was left in place in the patient.While the initial report the an intra-operative fracture occurred was received on (b)(6)2023, information was received 19jun2023 regarding the status of the implant and that it was not retreived, indicating that this report was reportable.According to the customer this occurred when the implant was impacted and then rotated into place at l4/5.While rotating it fractured and was left in place.The surgery was completed, and the broken cage left in place.No parts are available for inspection.
Additional Manufacturer Narrative
A patient underwent spinal surgery consisting of seaspine' s explorer to system.The index surgery took place on (b)(6) 2023.On (b)(6) 2023 seaspine became aware that an et1-383210 height expansion, 9mm x 32mm x 10-14mm, 8 deg fractured during a case and was left in place in the patient, indicating this complaint was now reportable.According to the customer this occurred when the implant was impacted and then rotated into place at l4/5.While rotating, it fractured and was left in place.The surgery was completed, and the broken cage left in place.No parts are available for inspection no root cause was identified as the device was left in situ upon fracture.There is no device for evaluation, and the x-ray images provided are not sufficient to determine the root cause.Review of labeling: possible adverse events, bending, disassembly, or fracture of implant and components.
Event or Problem Description
A patient underwent spinal surgery consisting of seaspine' s explorer to system.The index surgery took place on (b)(6) 2023.On (b)(6) 2023 seaspine became aware that an (b)(6) height expansion, 9mm x 32mm x 10-14mm, 8 deg fractured during a case and was left in place in the patient, indicating this complaint was now reportable.According to the customer this occurred when the implant was impacted and then rotated into place at l4/5.While rotating, it fractured and was left in place.The surgery was completed, and the broken cage left in place.No parts are available for inspection.

• Brand Name: EXPLORER TO SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: taara maharaj ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165150
• MDR Report Key: 17321969
• Report Number: 3012120772-2023-00011
• Device Sequence Number: 6365507
• Product Code: MAX
• UDI-Device Identifier: 10889981206758
• UDI-Public: 10889981206758
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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: ET1-383210
• Device Catalogue Number: ET1-383210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 07/28/2023
• 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
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Female