MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION WAVEFORM TO POSTERIOR LUMBAR INTERBODY

Model Number	WO1-928111
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The explant was returned, and the failure confirmed by seaspine product engineers.Replication testing was performed by inserting and rotating an implant from the same lot into the disc space between pcf 20 bone foam under 1000n of force.The failure mode could not be duplicated.Possible adverse events: bending, disassembly, or fracture of implant and components.
Event or Problem Description
On (b)(6) 2024, a patient underwent spinal surgery consisting of seaspine's waveform to posterior lumbar interbody system.The implant broke during insertion and rotation.Half of the implant was removed, however the tip remained forward in the space.The disc space was packed with graft to fill the void.The surgeon feels there was no harm done to the patient.

• Brand Name: WAVEFORM TO POSTERIOR LUMBAR INTERBODY
• Common Device Name: INTERBODY
• 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: 19477254
• Report Number: 3012120772-2024-00032
• Device Sequence Number: 11771103
• Product Code: MAX
• UDI-Device Identifier: 10889981235109
• UDI-Public: 10889981235109
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K213420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/06/2024

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: WO1-928111
• Device Catalogue Number: WO1-928111
• Device Lot Number: RD20081052A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2020
• 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
• Patient Sex: Unknown