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

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

On (b)(6) 2022, genesys spine received a complaint stating that a surgeon had experienced "serious complications" during implantation of the genesys spine ais-c cervical standalone system.Multiple requests for additional information have been made to the complainant but no additional information has been provided.Genesys spine is continuing attempts to obtain information and will file a supplemental report if more information is received.

• Brand Name: AIS-C CERVICAL STANDALONE SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION
• Manufacturer (Section D): GENESYS SPINE; 1250 s. capital of tx hwy; bldg 3, suite 600; austin TX 78746
• Manufacturer Contact: chloe lance ; 1250 s. capital of tx hwy; bldg 3, suite 600; austin, TX 78746 ; 5123817089
• MDR Report Key: 16080685
• MDR Text Key: 306495800
• Report Number: 3008455034-2022-00016
• 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: Other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other