MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPINEMAP® 3D 3.1 - SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6002-680-000
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility during a minimally invasive l4-s1 case after the doctor began inserting the k-wire and felt that the placement was not accurate.The customer confirmed the k-wires were not positioned in the bone and instead "riding the nerve route." the device was re-digitized and the surgeon placed new k-wires to complete the case without further issues.The procedure was completed successfully with the same device without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document the device evaluation.
Event or Problem Description
It was reported that during a procedure at the user facility during a minimally invasive l4-s1 case after the doctor began inserting the k-wire and felt that the placement was not accurate.The customer confirmed the k-wires were not positioned in the bone and instead "riding the nerve route." the device was re-digitized and the surgeon placed new k-wires to complete the case without further issues.The procedure was completed successfully with the same device without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: SPINEMAP® 3D 3.1 - 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: 15855101
• Report Number: 3015967359-2022-02345
• Device Sequence Number: 14716077
• Product Code: HAW
• UDI-Device Identifier: 07613327359954
• UDI-Public: 07613327359954
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K002732
• 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): 01/17/2023

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 Model Number: 6002-680-000
• Device Catalogue Number: 6002-680-000
• Device Lot Number: VERSION 3.1-19/09
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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