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

Model Number	1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of the inner shaft of an ais-c impaction inserter (part number gac110) broke off during insertion of the ais-c interbody.The surgeon retrieved the broken portion of the device intact and no further complications were reported.

• Brand Name: AIS-C CERVICAL STANDALONE SYSTEM
• Common Device Name: 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 (Section G): GENESYS SPINE; 1250 s. capital of tx hwy; bldg 3, ste 600; austin TX 78746
• Manufacturer Contact: bryan meinken ; 4901 vineland rd # 150; orlando, FL 32811
• MDR Report Key: 15372769
• Report Number: 3008455034-2022-00010
• Device Sequence Number: 1636171
• Product Code: OVE
• UDI-Device Identifier: M719GAC1100
• UDI-Public: +M719GAC1100/$$7FS20190507B
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2022

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
• Device Model Number: 1
• Device Catalogue Number: GAC110
• Device Lot Number: FS20190507
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown