MAUDE Adverse Event Report: SEASPINE, INC SHORELINE ACS SCREW

Model Number	85-3016
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The screws were not returned for evaluation.No definitive root cause could be established.Seaspine requested information on the delayed complaint report and revision surgery.No response was received.Possible adverse events: bending, disassembly, or fracture of implant and components postoperative fracture due to trauma, defects, or poor bone stock.
Event or Problem Description
On 15 sep 2023 seaspine was made aware that a shoreline system screw was fractured at the 1-year post-operative appointment.Additional information was received on 26 sep 2023 that screws were fractured on the bottom levels of both implants.The index surgery occurred on (b)(6) 2022.No further information on the original procedure was provided.It was noted that the first screw was fractured on (b)(6) 2023.No report had been received by the company at that time.Patient condition was not provided.A revision surgery occurred on (b)(6) 2023 consisting of a two-level corpectomy using ulrich solidity and seaspine admiral plate, c5-t1 pcf.

• Brand Name: SHORELINE ACS SCREW
• Common Device Name: SCREW
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 17889684
• Report Number: 3012120772-2023-00029
• Device Sequence Number: 6938916
• Product Code: OVE
• UDI-Device Identifier: 10889981125172
• UDI-Public: 10889981125172
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 10/06/2023

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: 85-3016
• Device Catalogue Number: 85-3016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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