MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SHORELINE INSERTER

Model Number	86-0010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The inserter was returned and evaluated by product engineering.The fracture was observed to be angled and approximately one thread away from the thread run out location on the inserter's inner draw rod.This suggests that the draw rod was either not fully threaded into the interbody while impacted, or that impaction occurred at angulation.No definitive root cause could be determined.Intraoperative warnings: breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.
Event or Problem Description
On (b)(6) 2024 a patient underwent spinal surgery consisting of seaspine's shoreline anterior cervical fixation system.During the procedure, the tip of the inserter broke off in the interbody implant.The surgeon opted to leave the implant with the broken inserter tip in-situ.No patient injury was reported.

• Brand Name: SHORELINE INSERTER
• Common Device Name: INSERTER
• 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: 19911748
• Report Number: 3012120772-2024-00059
• Device Sequence Number: 15654251
• Product Code: MAX
• UDI-Device Identifier: 10889981126889
• UDI-Public: 10889981126889
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2024

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: 86-0010
• Device Catalogue Number: 86-0010
• Device Lot Number: AL683477J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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