MAUDE Adverse Event Report: STRYKER SPINE-US NAVIGATION ENABLED SERRATO/ES2/XIA 3 DRIVER, CANNULATED; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	48702681
Medical Device Problem Codes	Difficult to Insert (1316); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a xia navigation enabled driver was disengaging from screws intra-operatively.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Event or Problem Description
It was reported that a xia navigation enabled driver was disengaging from screws intra-operatively.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Additional data: d9, h3.H6 coding has been updated to reflect completion of the investigation.

• Brand Name: NAVIGATION ENABLED SERRATO/ES2/XIA 3 DRIVER, CANNULATED
• Common Device Name: ORTHOPEDIC STEREOTAXIC 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: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 20984366
• Report Number: 0009617544-2024-00190
• Device Sequence Number: 18287796
• Product Code: OLO
• UDI-Device Identifier: 07613327460964
• UDI-Public: (01)07613327460964(11)230203(10)225095
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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 Catalogue Number: 48702681
• Device Lot Number: 225095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• 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