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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Perforation of Esophagus (2399); Hematemesis (4478)

Event Type  Injury  

Manufacturer Narrative

An initial complaint from the united arab emirates was received on (b)(6) 2022 that reported "serious complications" after implantation of the ais-c cervical stand-alone system (refer to mdr # 3008455034-2022-00016 & 3008455034-2023-00002).Four attempts at reaching the complainant for additional information were made.Due to a lack of comprehension (complainant is not fluent in english), all communications were initiated via email.These included emails sent on (b)(6) 2022, on (b)(6) 2022, on (b)(6) 2023, and on (b)(6) 2023.On (b)(6) 2023, a response to our investigation was received that is summarized below: two surgeons, (b)(6) implanted five (5) patients with ais-c cervical stand-alone system devices.Some time after implantation, one (1) patient began experiencing hematemesis and upon examination was found to have a perforated esophagus.Additionally, anchor migration was reported in two (2) additional patients that resulted in revision/removal of the ais-c cervical stand-alone system devices (refer to mdr # 3008455034-2023-00004 & 3008455034-2023-00005).The reported event was unable to be confirmed due to limited information received.The implanted parts and associated lot numbers involved in the event were not available, however a review of the manufacturing records for all lots of devices sent to the complainant was performed and no anomalies were found.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not sufficiently provided.There are warnings in the ais-c cervical stand-alone system instructions for use and surgical technique documentation that state that "the integrated fixation anchors may not provide adequate stability for all situations.The surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.G.Anterior plate, posterior cervical screw) may be needed." additionally, upon completion of the implantation, "visually confirm the anchors are fully deployed by ensuring the rear face of the anchors are partially covered by the interbody's lock.If the anchors did not fully deploy, an anchor finisher is available for use." there are also warnings that this type of event can occur."possible adverse effects include anterior or posterior migration of the implant and a loss of fixation." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Event Description

Some time after an initial ais-c cervical stand-alone procedure it was reported that the patient had a perforated esophagus and was experiencing hematemesis.The reported event was unable to be confirmed due to limited information 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, 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: 16413568
• MDR Text Key: 309949391
• Report Number: 3008455034-2023-00003
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K181295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2023
• 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): Required Intervention