MAUDE Adverse Event Report: SPINAL ELEMENTS, INC CERES CERVICAL PLATE SYSTEM; ANTERIOR CERVICAL PLATE

Model Number	12-150-0230
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not available for evaluation as the device remains in the patient.Patient is asymptomatic and there is no plan for revision surgery.Radiographs received, noted the center locking cam is approximately 2mm proud but still in contact with the plate the acp plate.The bone screw is not proud and does not suggest a mechanical force dislodged the component post operatively.Root cause of the locking cam detaching from the plate is unknown.
Event or Problem Description
Patient underwent an acdf surgery to fuse c4- c6 on (b)(6) 2021.During a routine two month follow up it was noted via radiograph, that the center locking cam on the acp plate came dislodged.Patient is asymptomatic and there is no current plan for revision.

• Brand Name: CERES CERVICAL PLATE SYSTEM
• Common Device Name: ANTERIOR CERVICAL PLATE
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer Contact: peter perhach ; 3115 melrose drive, suite 200; carlsbad, CA 92010 ; 7606071830
• MDR Report Key: 12801127
• Report Number: 3004893332-2021-00020
• Device Sequence Number: 5271062
• Product Code: KWQ
• UDI-Device Identifier: 00840916127602
• UDI-Public: 00840916127602
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K152455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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: 12-150-0230
• Device Catalogue Number: 12-150-0230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 11/11/2021
• 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
• Patient Sex: Male