MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPINE GUIDANCE SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 6002-710-000

Device Problem Incorrect Measurement (1383)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2023

Event Type  malfunction  

Event Description

Per the customer, the smart segmentation software projected screws in the canal, indicating an inaccuracy.Additional information has been requested from the user facility.

Manufacturer Narrative

Device evaluation: follow-up report submitted to document the device evaluation.

Event Description

Per the customer, the smart segmentation software projected screws in the canal, indicating an inaccuracy.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.

• Brand Name: SPINE GUIDANCE SOFTWARE
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16303880
• MDR Text Key: 309256511
• Report Number: 3015967359-2023-00367
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 07613327545883
• UDI-Public: 07613327545883
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220593
• 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: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 6002-710-000
• Device Catalogue Number: 6002-710-000
• Device Lot Number: VERSION: 4.0-16/016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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