MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MERIDIAN ANTERIOR LUMBAR INTERBODY SYSTEM

Model Number	RA2-004002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 the patient underwent spinal surgery utilizing seaspine's meridian anterior lumbar interbody system.During surgery, the tip of the ra2-004002 locking cover driver broke off into the plate it was securing.The tip was unable to be retrieved.The surgeon was not concerned, and no revision surgery is planned.
Additional Manufacturer Narrative
The driver shaft was received by seaspine on 15 sep 2022 and the tip confirmed to have been sheared completely off.The tip remains in situ.No images have been provided for analysis.The reporter noted that the surgeon used the driver with a non-torquing handle.Per the surgical technique, the driver is to be used with a torque-limiting handle to ensure excessive stress isn't introduced to the tip during use.Review of labeling: possible adverse events: pain, discomfort, or abnormal sensations due to the presence of the device.Intraoperative warnings: breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.

• Brand Name: MERIDIAN ANTERIOR LUMBAR INTERBODY SYSTEM
• Common Device Name: MERIDIAN ANTERIOR LUMBAR INTERBODY SYSTEM
• 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: taara maharaj ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 15710269
• Report Number: 3012120772-2022-00033
• Device Sequence Number: 6489791
• Product Code: MAX
• UDI-Device Identifier: 10889981216467
• UDI-Public: 10889981216467
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220711
• 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): 10/05/2022

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: RA2-004002
• Device Catalogue Number: RA2-004002
• Device Lot Number: TT0180B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown