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

Model Number 6002-710-000

Device Problems No Display/Image (1183); Incorrect Measurement (1383)

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

Event Date 01/17/2023

Event Type  malfunction  

Event Description

Per the customer, during a navigation case where images were being transferred from ziehm system to the q guidance system the surgeon used point to point registration and navigated actively for the first six screws.On the seventh screw, navigation cut out on all screens except the 3d model.Per the customer no buttons were used by the clinical specialist.The customer tried to re-register, push images over again, and reboot the system but was unable to reproduce the images.Back-up equipment was used to complete the procedure.No delay, no adverse consequences and no medical intervention were reported.

Manufacturer Narrative

Follow-up report submitted to document the device was not available for evaluation.H3 other text : device not returned.

Event Description

Per the customer, during a navigation case where images were being transferred from ziehm system to the q guidance system the surgeon used point to point registration and navigated actively for the first six screws.On the seventh screw, navigation cut out on all screens except the 3d model.Per the customer no buttons were used by the clinical specialist.The customer tried to re-register, push images over again, and reboot the system but was unable to reproduce the images.Back-up equipment was used to complete the procedure.No delay, no adverse consequences and no medical intervention 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: 16359921
• MDR Text Key: 309398497
• Report Number: 3015967359-2023-00398
• 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: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2023
• 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: UNKNWON
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2023
• 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