MAUDE Adverse Event Report: STRYKER SPINE-US INSERTER TRITANIUM C; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48989000
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the threading of a tritanium c inserter was "off" intra-operatively.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.Additional information received from the company representative indicated that the device was difficult to assemble and disassemble with a cage intra-operatively.

• Brand Name: INSERTER TRITANIUM C
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 24699435
• Report Number: 0009617544-2026-00052
• Device Sequence Number: 18751904
• Product Code: LXH
• UDI-Device Identifier: 07613327346671
• UDI-Public: (01)07613327346671(11)190507(10)18A227
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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 Catalogue Number: 48989000
• Device Lot Number: 18A227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/26/2026
• 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
• Patient Sex: Unknown