MAUDE Adverse Event Report: INNOSYS CO., LTD. ANAX 5.5 CT SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	CT6645
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The male patient had a surgery to insert four anax 5.5 st screws into l5-s1 on (b)(6) 2021.The surgeon found out that two screws (part no.: ct6645, lot no.: 19h05033) in s1 were broken on (b)(6) 2021 after reviewing the x-rays.We are investigating the cause of this issue with the returned screws.If the breakage occurred due to the product design, we will improve the screw.Additionally we have a plan to conduct a removal in the market if we need a design change.We cannot find any quality problem by reviewing the device history record (manufacturing & inspection) of the relevant products so far.The patient will continue to be monitored afterwards to see any contributing changes.We will follow-up report after further investigation.
Event or Problem Description
The male patient had a surgery to insert four anax 5.5 st screws into l5-s1 on (b)(6) 2021.The surgeon found out that two screws (part no.: ct6645) in s1 were broken on (b)(6) 2021 after reviewing the last set of x-rays.
Additional Manufacturer Narrative
*initial report - mfr report # : 9617297-2021-00009 1.Investigation 1-1.It is assumed that the repetitive loads from daily life on the surface step of the screw head, caused by the sanding process have resulted in the occurrence of micro-cracks and breakage of the screw.- we have confirmed a meaningful increase in the maximum fatigue strength of the screw, as we have reduced the sanding range on the screw head.2.Follow-up 2-1.Design change of all size (anax 5.5 ct spinal system bone screw(b type)) 2-2.Market withdrawal of anax 5.5 ct spinal system bone screw(b type) of d6.5 and d7.5 screws - since this screw breakage does not occur frequently in ct screw, we believe that if the user recognizes the above safety issues and keeps paying attention when selecting the appropriate screw size before the operation, there will be no problem in using the current screw.- to ensure additional safety, we replaced the d6.5 and d7.5 screws, which are heavily loaded and used in the lower part of the spine.2-3.We sent a anax 5.5 ct spinal system bone screw safety information(t.B.) to all customers.3.Patient's prognosis 3-1.There are no special findings in the patient's health that have been additionally confirmed so far.
Event or Problem Description
The male patient had a surgery to insert four anax 5.5 ct screws into l5-s1 on (b)(6) 2021.The surgeon found out that two screws (part no.: ct6645) in s1 were broken on (b)(6) 2021 after reviewing the last set of x-rays.

• Brand Name: ANAX 5.5 CT SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): INNOSYS CO., LTD.; 20; sandan-ro 76beon-gil(rd); uijeongbu-si, gyeonggi-do KOR 1 1781; KS KOR 11781
• Manufacturer Contact: ye-seul choi ; 20; sandan-ro 76beon-gil; uijeongbu-si, gteonggi-do 11781 ; KS 11781
• MDR Report Key: 12825821
• Report Number: 9617297-2021-00009
• Device Sequence Number: 14559416
• Product Code: NKB
• UDI-Device Identifier: 08800015998291
• UDI-Public: (01)08800015998291(11)190927(10)19H05033
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CT6645
• Device Catalogue Number: CT6645
• Device Lot Number: 19H05033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2019
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Male