MAUDE Adverse Event Report: Highridge Medical, LLC CURVE VARIABLE INSERTER; Intervertebral Fusion Device With Bone Graft, Lumbar

Catalog Number	14-533021
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the zyston curve inserter, the surgeon positioned the cage between the vertebral bodies in the straight configuration and attempted to rotate the dial on the handle to release the cage.However, the adjacent silver-colored component rotated together with the dial, preventing the dial from loosening.The dial was eventually loosened with the assistance of pliers.A boot-shaped impactor was used to rotate the mechanism, and the procedure was successfully completed.There was no patient or procedural impact.This is report one of two for this event.
Additional Manufacturer Narrative
Corrections in d4: lot & udi numbers, d9, and h3.Additional information in h4 and h6: investigation type, findings, and conclusions.A review of the dhr was conducted and found no indications of manufacturing issues.This event likely cannot be attributed to manufacturing or design related issues.An inspection of the part shows the device has disassembled.No damage to the separated components was observed.The complaint is confirmed for zyston inserter for the failure of disassembly.The failure could possibly be attributed to damage over time and repeated usage of the instruments leading to the disassembly.This device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference report 3012447612-2026-00229.

• Brand Name: CURVE VARIABLE INSERTER
• Common Device Name: Intervertebral Fusion Device With Bone Graft, Lumbar
• 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: 50459760
• Report Number: 3012447612-2026-00228
• Device Sequence Number: 10172193
• Product Code: MAX
• UDI-Device Identifier: 00888480470007
• UDI-Public: (01)00888480470007
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110650
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: 14-533021
• Device Lot Number: N31282
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/01/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown