MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MERIDIAN INTERBODY SYSTEM; ANGLED AWL FIXED

Model Number	RA2003015
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon analysis of the returned awl, it was found that the micro tig weld securing the awl components failed under impaction, causing the separation of critical components.The root cause of this failure was attributed to insufficient weld penetration, ultimately resulting in the weld failure under impaction during the procedure.There was no patient injury as a result of the product malfunction.
Event or Problem Description
On (b)(6) 2024, a patient underwent spinal surgery with seaspine's meridian interbody system.Seaspine received a complaint regarding the meridian angled awl fixed.During screw placement, the weld of the angled awl fractured, which subsequently prevented the implantation of the 2 l5 screws because the straight awl could not achieve the required angle.As a result, the surgeon proceeded with only 1 screw in s1 and no l5 fixation, opting to use percutaneous pedicle screws posteriorly instead, leading to a 30-minute procedural delay.

• Brand Name: MERIDIAN INTERBODY SYSTEM
• Common Device Name: ANGLED AWL FIXED
• 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: 19168538
• Report Number: 3012120772-2024-00010
• Device Sequence Number: 15417727
• Product Code: MAX
• UDI-Device Identifier: 10889981216368
• UDI-Public: 10889981216368
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/23/2024

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 Model Number: RA2003015
• Device Catalogue Number: RA2003015
• Device Lot Number: CR52893J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown