MAUDE Adverse Event Report: NIRAJ INDUSTRIES PVT. LTD. GLASSVAN; SURGICAL BLADE

Catalog Number	2003-312
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the right xlif procedure a foreign object was noted on x-ray after templating of interbody cage.Was determined to be a blade that had been extracted from instrument and remained in l2-3 level.A determination was made to remove the blade object in doing a left direct approach procedure to remove object which created a secondary procedure, and staging of case for a later date.The object was determined to be a myco medical glass van cs surgical blade.The ref #01999, lot #210311mc, expires: 11-22-2026, myco reorder #(b)(4).Myco medical phone # (b)(6).The object was removed and verified with x-ray that no other fragments were intact within left l4-l5 level of removing the object.
Event or Problem Description
Update: the factory conducted an investigation on retain samples of the same part number and lot number reported, and the samples met the factory's specifications for dimenstional tolerances, and handle fitment.The suspct device was not available for examination, as the end-user discarded it after ti was removed.A copy of the factory's report is included with this updated report.This concludes the investigation and we consider this complaint closed.On (b)(6) 2025: it was reported that during the right xlif procedure a foreign object was noted on x-ray after templating of interbody cage.Was determined to be a blade that had been extracted from instrument and remained in l2-3 level.A determination was made to remove the blade object in doing a left direct approach procedure to remove object which created a secondary procedure, and staging of case for a later date.The object was determined to be a myco medical glass van cs surgical blade.The ref #(b)(4), lot #210311mc, expires: 11-22-2026, myco reorder #(b)(4).Myco medical phone # (b)(6).The object was removed and verified with x-ray that no other fragments were intact within left l4-l5 level of removing the object.

• Brand Name: GLASSVAN
• Common Device Name: SURGICAL BLADE
• Manufacturer (Section D): NIRAJ INDUSTRIES PVT. LTD.; 923, sector - 68, imt; faridabad, haryana 12100 4; IN 121004
• MDR Report Key: 23222516
• Report Number: 1058382-2025-00003
• Device Sequence Number: 9502519
• Product Code: GES
• UDI-Device Identifier: 18904233119999
• UDI-Public: 18904233119999
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025
• Report Date (Section F): 10/06/2025

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 Catalogue Number: 2003-312
• Device Lot Number: 210311MC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/30/2025
• Device Age: 47 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 10/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/06/2025