MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SHORELINE NO PROFILE SPACER; INTERBODY IMPLANT

Model Number	85-0206-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Numbness (2415); Neck Pain (2433); Unspecified Nervous System Problem (4426)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explant was returned and evaluated by seaspine's product engineering team.The interbody was completely intact with no visible fractures.Normal wear consistent with the implantation period was observed.No failure mode or definitive root cause could be established.Possible adverse events: pain, discomfort, or abnormal sensations due to the presence of the device serious complications associated with any surgery may occur.These include, but are not limited to: infection, numbness, tingling, or pain.
Event or Problem Description
On (b)(6) 2023, a patient underwent spinal surgery consisting of seaspine's shoreline anterior cervical interbody system, novabone's synthetic bioglass bone graft, and dymicron's triadyme-c cervical disc.After six months, the patient began experiencing radicular pain, numbness, and cervical pain.On (b)(6) 2024 the patient underwent a revision surgery as they were "referring dural compression due to a pseudo-tumor." all previously implanted material was removed.No further information on the event or patient condition was provided.

• Brand Name: SHORELINE NO PROFILE SPACER
• Common Device Name: INTERBODY IMPLANT
• 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: 19950658
• Report Number: 3012120772-2024-00061
• Device Sequence Number: 12997255
• Product Code: MAX
• UDI-Device Identifier: 00889981124017
• UDI-Public: 00889981124017
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2024

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: Health Professional
• Device Model Number: 85-0206-S
• Device Catalogue Number: 85-0206-S
• Device Lot Number: EL2107043H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• 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