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  malfunction  

Event Description

On december 5, 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, including an anchor backing out of the interbody.Multiple requests for additional information have been made to the complainant but no additional information has been provided.A supplemental report will be filed if additional information is received.Note - genesys spine initially submitted mdr 3008455034-2022-00016.During review of the initial mdr, it was realized that there were two (2) devices involved and as such two (2) separate mdrs should have been filed.A corrective mdr was file [mdr 3008455034-2023-00001] to state that there were two (2) devices involved.Additionally, this mdr is being filed to address the second device involved.

• 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, ste 600; austin TX 78746
• Manufacturer Contact: chloe lance ; 1250 s. capital of tx hwy; bldg 3, ste 600; austin, TX 78746 ; 5123817089
• MDR Report Key: 16199768
• MDR Text Key: 308937366
• Report Number: 3008455034-2023-00002
• 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: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other