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

Catalog Number GAC-LG

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 12/26/2023

Event Type  Injury  

Manufacturer Narrative

No information was received regarding if an explant had occured.Based on the photo received, the hospital account was created (b)(6) 2023 and the scan showing the anchor back out was taken (b)(6) 2023.Several attempts to collect information about the device and event were made, however, no further contact was received.Was able to determine the device and lot number based on the hospital account creation date and the surgeon name.If additional information is received, a supplemental report will be submitted.

Event Description

Information recieved from treating surgeon that anchors had backed out of the implanted interbodies.

• Brand Name: AIS-C CERVICAL STAND-ALONE SYSTEM
• Type of Device: 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 78746 ; 5123817070
• MDR Report Key: 18680478
• MDR Text Key: 335075035
• Report Number: 3008455034-2024-00001
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GAC-LG
• Device Lot Number: AM20220601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other