MAUDE Adverse Event Report: GENESYS SPINE 3DP AIS-C II STAND-ALONE SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Catalog Number	GAC-LG
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On june 20, 2024 the representative for vsi surgical informed genesys spine via text message that during a follow-up appointment, an anchor was found to have backed out of the 3dp ais-c ii interbody.The doctor planned to perform a revision on (b)(6) 2024 and the representative would inform genesys spine on the results post op photos following surgery and photos taken during the follow-up appointment were received.On june 24, 2024 the representative for vsi surgical informed genesys spine that the revision procedure was completed on (b)(6), 2024, resulting in the loose anchor being extracted.The representative was not able to retrieve the extracted anchor to send to genesys spine for inspection.Genesys spine was made aware of the revision to explant the anchor on (b)(6), 2024.
Additional Manufacturer Narrative
Based on the investigation, the incident may have been caused by improper anchor deployment technique by the user.

• Brand Name: 3DP AIS-C II STAND-ALONE SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): GENESYS SPINE; 1250 s. capital of tx hwy; bldg 3, ste 600; austin TX 78746
• Manufacturer Contact: raquel brown ; 1250 s. capital of tx hwy; bldg 3, ste 600; austin, TX 78626
• MDR Report Key: 19820555
• Report Number: 3008455034-2024-00004
• Device Sequence Number: 15627038
• Product Code: OVE
• UDI-Device Identifier: M719GACLG0
• UDI-Public: +M719GACLG0/$$7AM202206010
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K233594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 07/24/2024

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 Catalogue Number: GAC-LG
• Device Lot Number: AM20220601
• 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: 06/24/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown