MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG NGENIUS UNIVERSAL TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 6000-014-000

Device Problems Incorrect Measurement (1383); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2024

Event Type  malfunction  

Event Description

It was reported that during a case, the ngenius universal tracker was not fully seated which caused the accuracy to be off.

Manufacturer Narrative

H6 coding has been updated to reflect investigation conclusion h3 other text : device will not been returned.

Event Description

It was reported that during a case, the ngenius universal tracker was not fully seated which caused the accuracy to be off.

• Brand Name: NGENIUS UNIVERSAL TRACKER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 18821744
• MDR Text Key: 337206645
• Report Number: 0008010177-2024-00017
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 04546540651563
• UDI-Public: 04546540651563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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
• Device Catalogue Number: 6000-014-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1