MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SHORELINE INTERBODY, 16X14X9MM, 15 DEGREE, STERILE; SPACER

Model Number	85-1709-S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was left implanted and therefore could not be evaluated.No revision surgery is planned.Review of labeling: do not implant the device past the expiration date.Use proper aseptic technique to transfer the contents of the sterile package to the surgical field.
Event or Problem Description
On (b)(6) 2024 a patient underwent spinal surgery utilizing seaspine's shoreline anterior cervical fixation system.A sterile interbody was implanted that had expired on (b)(6) 2024.It is unknown when the expiration date was noted by surgical staff.No patient injury was reported.

• Brand Name: SHORELINE INTERBODY, 16X14X9MM, 15 DEGREE, STERILE
• Common Device Name: SPACER
• 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: 19991773
• Report Number: 3012120772-2024-00064
• Device Sequence Number: 7075968
• Product Code: MAX
• UDI-Device Identifier: 00889981124901
• UDI-Public: 00889981124901
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K240830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/15/2024

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 Expiration Date: 05/14/2024
• Device Model Number: 85-1709-S
• Device Catalogue Number: 85-1709-S
• Device Lot Number: EL1903055F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2019
• 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: Other
• Patient Sex: Unknown