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

Model Number	12-30-0348
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Returned device was visually inspected, functionally tested and the complaint was confirmed.The device left locking mechanism/cam had disassembled from the plate.The device meets dimensional specifications.The cam is not marred/bent/damaged from over-rotation or being in contact with a proud screw.Unknown factors include: if the locking mechanisms were properly locked at time of implantation, if the cam was damaged/loosened as a result of handling in the field, patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability or patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort (no trauma was reported).Root cause is unknown.
Event or Problem Description
On (b)(6) 2022, patient underwent anterior cervical fusion (acdf) surgery with a three level anterior cervical plate (acp) c3-c6.During routine follow-up, radiographs depict the left c6 locking mechanism on the acp had disassociated.The bone screw has backed out 2-3 mm.Revision was performed on june 7, 2022, to replace the plate.

• Brand Name: CERES
• 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: 14777873
• Report Number: 3004893332-2022-00010
• Device Sequence Number: 14660706
• Product Code: KWQ
• UDI-Device Identifier: 00840916127343
• UDI-Public: (01)00840916127343(10)202449(11)210302
• 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: 2022
• Device Explanted Year: 2022
• 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): 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 12-30-0348
• Device Catalogue Number: 12-30-0348
• Device Lot Number: 202449
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male