MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION CORAL SPINAL SYSTEM; T-20 DRIVER

Model Number	10-40-0410
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Seaspine was made aware of this event on 15 apr 2021.The driver has not been made available for examination, and the tip remains in situ.Additionally, no images have ben provided for analysis.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.
Event or Problem Description
The patient underwent spinal surgery on (b)(6) 2020 consisting of seaspine's coral spinal system.During surgery, the 10-40-0410 t-20 driver tip broke when the surgeon was advancing a pedicle screw.The surgeon determined the tip could not be removed from the screw head and completed the case.The patient complained of pain and received an mri.The surgeon concluded their pain is related to diabetic neuropathy and not related to the driver tip which remains in the screw head.At this time, there is no plan for revision surgery, and the surgeon continues to monitor the patient's recovery.

• Brand Name: CORAL SPINAL SYSTEM
• Common Device Name: T-20 DRIVER
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• MDR Report Key: 11820097
• Report Number: 3012120772-2021-00040
• Device Sequence Number: 3792442
• Product Code: NKB
• UDI-Device Identifier: 10889981106768
• UDI-Public: 10889981106768
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 05/12/2021

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
• Operator of Device: Health Professional
• Device Model Number: 10-40-0410
• Device Catalogue Number: 10-40-0410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1