MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG SPINEMAP® 3D 3.1 - SOFTWARE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	6002-680-000
Medical Device Problem Codes	Imprecision (1307); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced arterial bleeding during a navigated c1-c2 posterior fusion case.The surgeon successfully implanted non-stryker screws (depuy) on the left side.During preparation for placement of the right side, non-stryker c1 screw (depuy), the surgeon noted, " the patient started to bleed." the spinous process clamp was removed and the bleeding was stabilized.The surgeon then re-registered the patient and the navigated drill guide and was satisfied with the accuracy.The surgeon was advancing the drill a second time and the patient started to bleed again.The procedure was not completed as planned and the patient received a blood transfusion.It was reported that at their 7 day post operative check-up, the patient was fine.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.Corrected data: g4.
Event or Problem Description
It was reported that a patient experienced arterial bleeding during a navigated c1-c2 posterior fusion case.The surgeon successfully implanted non-stryker screws (depuy) on the left side.During preparation for placement of the right side, non-stryker c1 screw (depuy), the surgeon noted, " the patient started to bleed." the spinous process clamp was removed and the bleeding was stabilized.The surgeon then re-registered the patient and the navigated drill guide and was satisfied with the accuracy.The surgeon was advancing the drill a second time and the patient started to bleed again.The procedure was not completed as planned and the patient received a blood transfusion.It was reported that at their 7 day post operative check-up, the patient was fine.

• Brand Name: SPINEMAP® 3D 3.1 - SOFTWARE
• Common Device Name: 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: 19767370
• Report Number: 0008010177-2024-00065
• Device Sequence Number: 20960709
• Product Code: OLO
• UDI-Device Identifier: 07613327359954
• UDI-Public: 07613327359954
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172034
• 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): 11/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 6002-680-000
• Device Lot Number: 16503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 13 YR
• Patient Sex: Unknown