MAUDE Adverse Event Report: GS MEDICAL CO. LTD GS MEDICAL PULSAR EXPANDABLE PLIF CAGE

Model Number	2210-0941
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon review of the design history record, it was confirmed that all procedures were performed normally and the product was shipped normally.All product labels for the same period were also reviewed, with no unusual or abnormal signs found.We conducted an additional review of similar customer complaints both domestically and internationally, and confirmed that no similar cases occurred in korea or in any other country outside of the united states.Research of the stock availability revealed there was no separate stock of this product available as this product is produced based on purchase orders.An additional investigation will be conducted if the actual device can be acquired.This will allow us to conduct a more accurate and reliable root cause analysis.
Event or Problem Description
[supplier] had a brief discussion with the surgeon and the representative about the cage collapsing 6 months post op.The surgeon explained that he implanted the expandable cage, initially expanded it and torqued it out, then allowed it to sit momentarily to build pressure.He subsequently re-engaged to further expand and torque it in an effort to achieve additional height.The torqueing of the cage multiple times with different heights is not compliant with the ifu.During the routine 6 month follow up, xrays were taken and the surgeon saw that the implant was no longer expanded.The patient had no clinical symptoms (pain, loss of function, inc).Therefore, the surgeon concluded no intervention was required.

• Brand Name: GS MEDICAL PULSAR EXPANDABLE PLIF CAGE
• Common Device Name: PULSAR EXPANDABLE PLIF CAGE
• Manufacturer (Section D): GS MEDICAL CO. LTD; #90 osongsaeng myeong 4-ro; cheongju-si; heungdeok-gu, chungcheongbuk-do 28161 ; KS 28161
• Manufacturer Contact: hoonpil park ; 90 osongsaengmyeong 4-ro; cheongju-si; heungdeok-gu, chungcheongbuk-do 28161 ; KS 28161
• MDR Report Key: 22519102
• Report Number: 3005596514-2025-00001
• Device Sequence Number: 8012066
• Product Code: MAX
• UDI-Device Identifier: 08800104089626
• UDI-Public: 0108800104089626
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K221687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

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: 2210-0941
• Device Lot Number: 240718072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2024
• 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
• Patient Sex: Unknown