MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M

Model Number UNK_OARM_SYS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Thrombosis/Thrombus (4440)

Event Date 03/01/2021

Event Type  Injury  

Event Description

Detchou, d.K., glauser, g., dimentberg, r., schuster, j.M., malhotra, n.R.Case series of ultrasonic navigated osteotomy for the treatment of spinal chordomas.World neurosurgery.150: e347-e352 https://doi.Org/10.1016/j.Wneu.2021.03.001 - background: chordomas present challenges for en bloc surgical resection, which optimally reduces local recurrence and increases pa tient survival.Navigated ultrasonic osteotomy, also known as piezosurgery, provides a distinct advantage for achieving negative margins after en bloc resection.- methods: eight consecutive patients with chordomas (2 cervical, 3 lumbar, and 3 sacral) treated with navigated ultrasonic osteotomy to achieve en bloc resection were identified from our institutional spine tumor database (2016e2019) and retrospectively reviewed.- results: en bloc resection, with negative margins, was achieved in all cases.Two patients (25%) were women, and mean age at surgery was 44 11 years.Median estimated blood loss was 1000 ml (interquartile range: 263e1500 ml).Median length of hospital stay was 10 days (interquartile range: 3e19.5 days).Two patients required a revision procedure.Two patients had complications requiring readmission within the 30-day postoperative window.Mean duration of follow-up for the cohort was 900 554 days.Conclusions: navigated ultrasonic osteotomy is an effective surgical technique to achieve en bloc resection of chordomas with negative margins and disease-free survival.To date, this represents the first reported cohort of patients undergoing the procedure as described here.Future studies should include larger sample sizes for more robust clinical outcome data to further elucidate the benefits of piezosurgery for obtaining en bloc chordoma resection.Reported events: two patients (25%) required a revision procedure.One of the revision procedures was complicated by intraoperative hemorrhage (6500 ml).Two patients had complications requiring readmission within the 30- day postoperative window.One patient had a surgical site infection, and the other patient had a deep vein thrombosis.

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patients in the study.Patient weight not available from the site.Event date is the accepted date of the literature article.Device lot number, or serial number, unavailable.510(k) is dependent upon the device model number and is therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacture date is dependent on the device lot/serial number, therefore is unavailable.

• Brand Name: O-ARM IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12865017
• MDR Text Key: 286017060
• Report Number: 3004785967-2021-01318
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2021

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
• Device Operator: Health Professional
• Device Model Number: UNK_OARM_SYS
• Device Catalogue Number: UNK_OARM_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 44 YR
• Patient Sex: Male