MAUDE Adverse Event Report: SEASPINE, INC SHORELINE ANTERIOR CERVICAL SYSTEM; SHORELINE INTERBODY, 18X15X7MM, 10 DEGREE, STERILE

Model Number	85-1407-S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported a shoreline cervical standalone cage migrated.No product lot information, explants, radiographs or ct scans have been received.A return of the product has been initiated but the device has not been received.Revision surgery was completed with no complications and anterior fixation was installed.Review of labeling: 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.Pain, discomfort, or abnormal sensations due to the presence of the device.
Event or Problem Description
Unknown index surgery was performed on an unknown date.No anterior fixation was used.After the surgery the patient experienced pain in the right hand.The interbody had migrated anterior to the intervertebral space and had to be replaced.An anterior cervical discectomy and fusion (acdf) revision surgery was performed on (b)(6) 2021 with anterior fixation.

• Brand Name: SHORELINE ANTERIOR CERVICAL SYSTEM
• Common Device Name: SHORELINE INTERBODY, 18X15X7MM, 10 DEGREE, STERILE
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 12363393
• Report Number: 3012120772-2021-00071
• Device Sequence Number: 19736117
• Product Code: OVE
• UDI-Device Identifier: 00889981124765
• UDI-Public: 00889981124765
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K201646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 08/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: 85-1407-S
• Device Catalogue Number: 85-1407-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other