MAUDE Adverse Event Report: GENESYS SPINE TILOCK2 SPINAL SYSTEM; SPINAL PEDICLE SCREW SYSTEM

Model Number	G711-65-45
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A distributor informed genesys spine that dr.(b)(6) discovered on x-ray a broken 6.5mm diameter tilock2 pedicle screw (originally implanted in 2020 or 2021, l4 to s1 fusion) when doing a planned implant of additional adjacent screws.Revision of the broken screw head and screw took place during the same day.The screw body was misplaced but the screw head was returned the week of (b)(6) 2024.No patient symptoms or complaints were noted that indicated a broken screw prior to the x-ray identification.Distributor indicated that the broken screw was only removed because of interference with the planned implants.Bony fusion had been achieved at l4-s1 prior to the screw fracture.According to genesys spine vp of field services, the screw chosen at implant may be undersized for the intended location and application, and ideally would have been either a 7.5mm or 8.5mm screw.

• Brand Name: TILOCK2 SPINAL SYSTEM
• Common Device Name: SPINAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): GENESYS SPINE; 1250 capital of texas hwy; bldg 3, suite 600; austin TX 78746
• Manufacturer (Section G): GENESYS SPINE; 1250 s. capital of texas hwy; bldg 3 suite 600; austin TX 78746
• Manufacturer Contact: kevin posey ; 1250 south capital of texas hwy; bldg 3, suite 600; austin, TX 78746 ; 5123817071
• MDR Report Key: 19939325
• Report Number: 3008455034-2024-00005
• Device Sequence Number: 7413942
• Product Code: NKB
• UDI-Device Identifier: M719G71165450
• UDI-Public: +M719G71165450/$$7TI20190614J
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2024

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
• Operator of Device: Health Professional
• Device Model Number: G711-65-45
• Device Catalogue Number: G711-65-45
• Device Lot Number: TI20190614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose