MAUDE Adverse Event Report: SEASPINE INC. CABO ANTERIOR CERVICAL PLATE; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	81-0472
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was communicated that a revision surgery took place to remove and replace a screw that had backed out (c7).During revision surgery, it was noticed the locking mechanism had broken and detached (c7).During removal of screws one screw broke (c3).All screws and plate were removed and replaced with new plating system.Review of labeling notes: possible adverse events: postoperative fracture due to trauma, defects or poor bone stock.Postoperative warnings: the patient should be advised that implants may bend, break or loosen despite restriction in activity.Dhr review: during the review of the dhr for the lot , it was concluded that the product was inspected and accepted for use by the quality control department and met all specified parameters of the receiving inspection report with no associated nonconformance specific to the product issue.It was reported the patient sustained a traumatic hit during a football game.The patient's anatomical condition and its effects on the stability of the implant and/or construct are unknown contributing factors.The root cause is unknown, but the patient's sustained impact may have caused or contributed to the event.
Event or Problem Description
On (b)(6) 2018, patient underwent a four level acf surgery with the cabo plate system.It was reported patient sustained a heavy, traumatic hit during a football game.Follow-up exam showed cabo screw had backed out (c7).Revision surgery occurred (b)(6) 2018.During revision surgery, it was noticed locking mechanism had broken and detached (c7).During removal of screws one screw broke (c3).All screws and plate were removed and replaced with new plating system.Patient is doing fine, and surgeon continues to monitor.

• Brand Name: CABO ANTERIOR CERVICAL PLATE
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SEASPINE INC.; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 8122851
• Report Number: 3012120772-2018-00027
• Device Sequence Number: 13501075
• Product Code: KWQ
• UDI-Device Identifier: 10889981160562
• UDI-Public: 10889981160562
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2018

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: 81-0472
• Device Lot Number: 15034533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 12/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR