MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SHORELINE ACS INTERBODY SYSTEM; 7MM, LOCKING COVER

Model Number	85-2107
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explants were not returned for analysis as the patient opted to keep them.Further information such as lot numbers and x-rays were not provided.As a result, we were unable to determine the underlying cause of the failure.Possible adverse events like other spinal system implants, the following adverse events are possible.This list is not exhaustive: 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.
Event or Problem Description
Seaspine became aware on 25 apr 2024, that a revision surgery took place on (b)(6) 2024, due to loosening of a locking cover and screw following the initial surgery on (b)(6) 2024.

• Brand Name: SHORELINE ACS INTERBODY SYSTEM
• Common Device Name: 7MM, LOCKING COVER
• 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: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 19308682
• Report Number: 3012120772-2024-00015
• Device Sequence Number: 7333047
• Product Code: OVE
• UDI-Device Identifier: 10889981125080
• UDI-Public: 10889981125080
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/13/2024

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: 85-2107
• Device Catalogue Number: 85-2107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 3D PRINTED INTERBODY SYSTEM AC4-164087; 3D PRINTED INTERBODY SYSTEM AC4-264077
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown