MAUDE Adverse Event Report: SEASPINE, INC SHORELINE; INSERTER, STRAIGHT

Model Number	86-0012
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of labeling: possible adverse events: bending, disassembly or fracture of implant and components.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) 2021, surgeon used a shoreline inserter (86-0012) to implant a waveform c implant.During the procedure, it was observed that the distal tip of the shoreline inserter had snapped off and the fragment remained in the interbody.The surgery was noted to have completed with no complications.It is unknown if all fragments were removed and accounted for.Unknown if fragments were removed and accounted for.

• Brand Name: SHORELINE
• Common Device Name: INSERTER, STRAIGHT
• Manufacturer (Section D): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE, INC; 5770 armada drive; carlsbad CA 92008
• Manufacturer Contact: joseph bautista ; 5770 armada drive; carlsbad, CA 92008
• MDR Report Key: 13015625
• Report Number: 3012120772-2021-00088
• Device Sequence Number: 17425016
• Product Code: OVE
• UDI-Device Identifier: 10889981162696
• UDI-Public: 10889981162696
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

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
• Device Model Number: 86-0012
• Device Catalogue Number: 86-0012
• Device Lot Number: BT059045B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WAVEFORM C
• Patient Sex: Unknown