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

Catalog Number	6002-710-000
Medical Device Problem Codes	Incorrect Measurement (1383); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, it was reported that during a surgery the user could not remove the backboard from the ct scan and wasn't able to visualize the anatomical points for registration.Surface matching was inaccurate by "~2cm." the procedure was completed successfully without a clinically significant surgical delay; no medical intervention or adverse consequences were reported.
Event or Problem Description
Per the customer, it was reported that during a surgery the user could not remove the backboard from the ct scan and wasn't able to visualize the anatomical points for registration.Surface matching was inaccurate by "~2cm." the procedure was completed successfully without a clinically significant surgical delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Update: d9, h3, h6 correction: follow-up report submitted to document the device log files were not available for evaluation.Correction: follow-up report submitted to document the device code has been updated.H3 other text : log files not submitted by customer for evaluation.

• Brand Name: SPINE GUIDANCE SOFTWARE
• Common Device Name: 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: 17994382
• Report Number: 3015967359-2023-02401
• Device Sequence Number: 6123533
• Product Code: HAW
• UDI-Device Identifier: 07613327545883
• UDI-Public: 07613327545883
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K220593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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: 6002-710-000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 01/01/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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