MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SHORELINE ANTERIOR CERVICAL SYSTEM; LOCKING COVER

Model Number	85-2108
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.No explants were made available for evaluation; however, review of the x-ray provided confirmed the report of postoperative implant separation.Photos of the explanted locking cover and interbody were received.There were no markings or fractures of either device that could aid in determining the cause of the failure.A revision surgery occurred on (b)(6) 2022.The patient showed did not exhibit any negative symptoms as a result of the implant failure.The locking cover and mating interbody were replaced.
Event or Problem Description
A patient underwent cervical spinal surgery on (b)(6) 2022, which consisted of seaspine's waveform c and shoreline interbodies.Seaspine was made aware on (b)(6) 2022 of a postoperative implant failure.

• Brand Name: SHORELINE ANTERIOR CERVICAL SYSTEM
• Common Device Name: 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
• MDR Report Key: 15895783
• Report Number: 3012120772-2022-00054
• Device Sequence Number: 5218910
• Product Code: MAX
• UDI-Device Identifier: 10889981125097
• UDI-Public: 10889981125097
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 11/29/2022

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: 85-2108
• Device Catalogue Number: 85-2108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 12/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEASPINE WAVEFORM C.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male