MAUDE Adverse Event Report: NANOHIVE MEDICAL, LLC HIVE STANDALONE CERVICAL SYSTEM PLATED; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	08-A-0101-4007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 2/3/2025, third party agent requested from nanohive an implant removal set for a cervical standalone plated implant.Initial implantation surgery occurred on (b)(6) 2024 and was a two level anterior cervical discectomy fusion procedure.The third-party agent was present at this surgery and it reportedly went well.Approximately 5 months post-surgery, the patient reported pain but subsequent mri results reportedly showed no issues.The patient went to another surgeon and revision surgery occurred on (b)(6) 2025.The agent helped facilitate the instruments for removal.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
Devices are not expected to be returned for manufacturer evaluation.No radiographs or imaging from pre-op, intra-op, post-op, or post revision surgery were provided.No further clarification to the location or severity of pain was provided.The contact information for the revising surgeon was not provided.Multiple requests for additional information were made by nanohive.A review of the dhr showed no issues for the lot numbers provided.No product malfunction was alleged and no root cause could be determined with the information provided.This regulatory report is being submitted due to retrospective review with the nanohive medical chief medical officer.Based on the information available, it has been determined that no corrective and preventative action is proposed.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a supplemental report will be filed accordingly.This report involves one cervical standalone plated implant.This is report 2 of 9.

• Brand Name: HIVE STANDALONE CERVICAL SYSTEM PLATED
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): NANOHIVE MEDICAL, LLC; 12 gill st; suite 4500; woburn MA 01801
• Manufacturer Contact: christy rickrode ; 12 gill st; suite 4500; woburn, MA 01801 ; 8449435433
• MDR Report Key: 21756639
• Report Number: 3013462427-2025-00003
• Device Sequence Number: 9821717
• Product Code: OVE
• UDI-Device Identifier: 00817493025072
• UDI-Public: (01)00817493025072(11)230406(17)330406(10)GM005746
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K223190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 08-A-0101-4007
• Device Catalogue Number: 08-A-0101-4007
• Device Lot Number: GM005746
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3.5 X 14MM BONE SCREWS; 4.0 X 16 MM BONE SCREW; HIVE STANDALONE CERVICAL PLATED - SMALL PLATE; HIVE STANDALONE CERVICAL SYSTEM, PLATED
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male