MAUDE Adverse Event Report: NANOHIVE MEDICAL, LLC HIVE STANDALONE CERVICAL SYSTEM, ZERO PROFILE; Intervertebral fusion device with integrated fixation, cervical

Model Number	08-A-2006-4006
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Devices are not expected to be returned for manufacturer evaluation as it remains in-situ.Radiographs of 2 weeks post-op were provided.No radiographs or imaging from intra-op or immediate post-op were provided.Multiple requests were made to obtain additional radiographs or imaging, as well as an interview with the operating surgeon.A review of the dhr showed no issues for the lot numbers provided.No root cause could be determined with the information provided.It is suspected that the cover plate was dislocated during the original implantation, similarly to other known misuses.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.
Event or Problem Description
On 7/2/2025, third party agent reported to nanohive that during a routine 2-week post-op follow up on (b)(6) 2025, radiograph imaging revealed the cover plate was found to be partially dislocated from the interbody.A patient x-ray taken during the 2 week post-operative follow up was provided which appears to show the cover plate protruding from the interbody.The same x-ray showed the interbody and screws to be in the expected and correct position with no signs of screw loosening.It was reported that the patient was asymptomatic and doing well.Revision is not currently planned and has not been scheduled.The surgeon will continue to monitor the patient.There were no further complications reported regarding the event.This submission is 1 of 1 devices involved in this event.

• Brand Name: HIVE STANDALONE CERVICAL SYSTEM, ZERO PROFILE
• 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: 22680983
• Report Number: 3013462427-2025-00011
• Device Sequence Number: 21194204
• Product Code: OVE
• UDI-Device Identifier: 00817493024921
• UDI-Public: (01)00817493024921(11)250109(17)350109(10)GM010239
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K223190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 07/31/2025

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-2006-4006
• Device Catalogue Number: 08-A-2006-4006
• Device Lot Number: GM010239
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2025
• 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: 3.5X14MM BONE SCREWS
• Patient Age: 58 YR
• Patient Sex: Male