MAUDE Adverse Event Report: Highridge Medical, LLC 3-LEVEL 51MM FIXED PLATE; Appliance, Fixation, Spinal Intervertebral Body

Catalog Number	14-522351
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a maxan 3 level plate ring dislodged upon final tightening of 4th screw placed.There was a delay of 5 minutes, with all 4 screws removed, a new plate used, and the screws put back in.There was no patient harm.
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

• Brand Name: 3-LEVEL 51MM FIXED PLATE
• Common Device Name: Appliance, Fixation, Spinal Intervertebral Body
• Manufacturer (Section D): Highridge Medical, LLC; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): Highridge Medical, LLC; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; +1(303)501-8506
• MDR Report Key: 50949432
• Report Number: 3012447612-2026-00251
• Device Sequence Number: 16059551
• Product Code: KWQ
• UDI-Device Identifier: 00880304960893
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K133518
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/29/2026

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 Catalogue Number: 14-522351
• Device Lot Number: J7337384
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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