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

Model Number	12-30-0114
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not available for evaluation as the device remains in the patient.Patient is asymptomatic, the bone screws have not moved and there is no plan for revision surgery.Dhr review cannot be completed at this time as the lot number was not provided.Radiographs received depict the c4 locking mechanisms on the acp have disassociated.Radiographs confirm the complaint.Unknown factors include: if the locking mechanisms were properly locked at time of implantation, patient activity at the time or prior to the event, 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 one level anterior cervical plate (acp) c3-c4.Patient had follow-up on (b)(6) 2022, radiographs received depict the c4 locking mechanisms on the acp have disassociated.The bone screws remain in original position.There is no plan for revision.

• Brand Name: AMENDIA 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: 14220468
• Report Number: 3004893332-2022-00008
• Device Sequence Number: 5563219
• Product Code: KWQ
• UDI-Device Identifier: 00840916127145
• UDI-Public: 00840916127145
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K152455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 04/27/2022

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: 12-30-0114
• Device Catalogue Number: 12-30-0114
• 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: 04/21/2022
• Initial Report FDA Received Date: 04/27/2022
• 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 Age: 66 YR
• Patient Sex: Male