MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MERIDIAN; INTERBODY INSERTER

Model Number	RA2-001003
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	01/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Seaspine was made aware of this event on 11 mar 2021.The inserter was not made available for analysis.No additional details about the patient's condition or treatment plan have been communicated to seaspine.During review of the device history record for lot cr43030a, it was concluded that the product was inspected and accepted for use by the quality control team on 11 aug 2020.The lot met all specified parameters of the receiving inspection report with no associated nonconformance related to the issue of sticking and not releasing.Following complaints of difficult interbody release, design changes have been incorporated into the inserter to address the issue of sticking or poor release functionality.Review of labeling: possible adverse events: serious complications associated with any surgery may occur.These include, but are not limited to: wound complications, infection, genitourinary disorders, gastrointestinal disorders, vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; bursitis, hemorrhage, myocardial infarction, paralysis or death.
Event or Problem Description
On (b)(6) 2021, the patient underwent l3-l5 alif spinal surgery using the seaspine meridian system.During surgery, the interbody inserter would not disengage from the interbody, necessitating removal of the interbody.Because of this a vessel was nicked, causing significant bleeding.The vascular surgeon had to intervene to prevent further bleeding.The case was completed with no additional intervention needed.The patient has not experienced any post operative complications.

• Brand Name: MERIDIAN
• Common Device Name: INTERBODY INSERTER
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• MDR Report Key: 11614886
• Report Number: 3012120772-2021-00028
• Device Sequence Number: 3099848
• Product Code: MAX
• UDI-Device Identifier: 10889981216108
• UDI-Public: 10889981216108
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200879
• 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): 04/05/2021

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: RA2-001003
• Device Catalogue Number: RA2-001003
• Device Lot Number: CR43030A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 04/05/2021
• 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: Required Intervention