MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION FIXED ANGLE LOCKING SCREW, 4.3MM DIA. X 15MM

Model Number	RA1-504315
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No products were returned as they were discarded by the hospital.No definitive root cause could be established.
Event or Problem Description
On (b)(6) 2024, a patient underwent spinal surgery utilizing seaspine's meridian anterior lumbar interbody system.It was reported that the surgeon had difficulty seating the screws into the 4-hole interbodies, resulting in a 30-45 minute surgical delay.Implanted screws were successfully placed.No patient injury was reported.

• Brand Name: FIXED ANGLE LOCKING SCREW, 4.3MM DIA. X 15MM
• Common Device Name: SCREW
• 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: 20146295
• Report Number: 3012120772-2024-00084
• Device Sequence Number: 8397419
• Product Code: MAX
• UDI-Device Identifier: 10889981310417
• UDI-Public: 10889981310417
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 09/05/2024

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: RA1-504315
• Device Catalogue Number: RA1-504315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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