MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INTELLECT CRANIAL NAVIGATION SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 6000-651-000

Device Problem Imprecision (1307)

Patient Problems Therapeutic Effects, Unexpected (2099); Blood Loss (2597)

Event Date 01/15/2016

Event Type  Injury  

Event Description

It was alleged that during a surgical procedure the intellect cranial navigation software was inaccurate approximately 15 mm to the right, leading to the incorrect placement of a burr hole in the patients' parietal region of the brain.It was further reported that when the unexpected bleeding occurred, the surgeons determined that the navigation was inaccurate.The bleeding was controlled, without further issue.Additional images were taken with an o-arm to confirm the accuracy, however, the procedure was aborted after a 3 hour delay and additional anesthesia administered.The procedure was completed 3 days later and it was reported that the patient was doing well.

Manufacturer Narrative

The reported event of incorrect placed craniotomy can be confirmed during review of the patient folder.It is visible that the planned approach on the mr scan is different from the position of the craniotomy as shown on the imported intra-operative ct images.During review it was identified that the fiducial markers changed from the pre-operative mr compared to the intra-operative ct scan.As the ct scans were performed intra-operative, this should be the real position of the fiducial marker.However the patient was never registered to a ct scan.No issues related to the reported event were identified as a result of the software.

Event Description

It was alleged that during a surgical procedure, the intellect cranial navigation software was inaccurate approximately 15 mm to the right, leading to the incorrect placement of a burr hole in the patients's arietal region of the brain.It was further reported that when the unexpected bleeding occurred, the surgeons determined that the navigation was inaccurate.The bleeding was controlled, without further issue.Additional images were taken with an o-arm to confirm the accuracy, however, the procedure was aborted after a 3 hour delay and additional anesthesia administered.The procedure was completed 3 days later and it was reported that the patient was doing well.

• Brand Name: INTELLECT CRANIAL NAVIGATION SOFTWARE
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5433631
• MDR Text Key: 38102778
• Report Number: 0001811755-2016-00183
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6000-651-000
• Device Lot Number: VERSION 1.1-14
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2016
• Initial Date FDA Received: 02/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2016
• 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
• Patient Outcome(s): Other