MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SHORELINE ACS; INTERBODY, 14X13X10MM, 7 DEGREE, STERILE

Model Number	85-0810-S
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent spinal surgery on (b)(6) 2025 utilizing the seaspine/orthofix shoreline acs system.Seaspine/orthofix became aware on 23 sep 2025 that a revision surgery occurred as a result of the inability to apply the interbody locking mechanism, rendering the construct potentially unstable.
Additional Manufacturer Narrative
It was reported by the distributor representative present during the surgery that the surgeon utilized instrumentation that was not intended for the implant selected, which resulted in the inability to apply the locking mechanism.The surgeon was unable to confirm the integrity of the construct via fluoroscopy.A ct scan was performed on (b)(6) 2025 and resulted in the decision to replace the interbody and accompanying screws.No patient injury was reported.The customer was unable to locate the explanted parts; therefore, the product was not returned for evaluation.Review of labeling: intraoperative warnings breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.Possible adverse events 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.

• Brand Name: SHORELINE ACS
• Common Device Name: INTERBODY, 14X13X10MM, 7 DEGREE, STERILE
• 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: danielle nelson-archer ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 23342658
• Report Number: 3012120772-2025-00054
• Device Sequence Number: 7957049
• Product Code: OVE
• UDI-Device Identifier: 00889981124444
• UDI-Public: 00889981124444
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K170569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 10/20/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 85-0810-S
• Device Catalogue Number: 85-0810-S
• Device Lot Number: EM2405027J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 85-3212 3.5MM VARIABLE SCREW, SELF-DRILLING, 12MM
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown