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

Model Number UNK_OARM_SYS

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

Patient Problem Burn(s) (1757)

Event Date 11/22/2019

Event Type  Injury  

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 publication.Device lot number, or serial number, unavailable.) 510(k) is directly related to the product number and is therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Concomitant medical products: other relevant device(s) are: product id: unk nav sys, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: ran ankory, assaf kadar, doron netzer, haggai schermann, yair gortzak, shlomo dadia, yehuda kollander, and ortal segal.3d imaging and stealth navigation instead of ct guidance for radiofrequency ablation of osteoid osteomas: a series of 52 patients.Bmc musculoskeletal disorders.2019 20.Https://doi.Org/10.1186/s12891-019-2963-8 background: osteoid osteomas are benign bone neoplasms that may cause severe pain and limit function.They are commonly treated by r adiofrequency ablation (rfa) through a needle inserted into the nidus of the lesion under ct guidance, which is associated with exposure of young patients to relatively high dose of radiation.The objective of this study was to investigate the amount of radiation, effectiveness and safety of an alternative imaging approach, the 3d image-guided (o-arm) technology and the stealth navigation.Methods: we retrospectively reviewed 52 electronic medical files of patients (mean age 24.7 years, range 8¿59 years) who were treated with thermal ablation of benign osteoid osteomas guided by the navigated o-arm-assisted technique in our institution between 2015 and 2017.Data were extracted on the associated complications, the reduction in pain at 3months and one year postoperatively, and the amount of radiation administered during the procedure.Results: the level of pain on a visual analogue scale decreased from the preoperative average of 7.73 to 0 at the 3- month follow-up.The mean dose-length product was 544.7 mgycm2 compared to the reported radiation exposure of 1971¿7946 mgycm2 of ct-guided radio ablations.The one intra-operative complication was a superficial burn in the subcutaneous lesion in a tibia that was treated locally with no major influence on recovery.Conclusions: rfa ablation guided by 3d o-arm stealth navigation is as effective as the traditional ct-guided technique with the advantage of lower radiation exposure.Reported events: intra-operative, one patient experienced a superficial burn who had a lesion in the tibia.The burn was reported to be due to the lesion's location in a relatively subcutaneous part of the tibia, and it was treated locally without any major sequelae.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• 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: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10809286
• MDR Text Key: 215882025
• Report Number: 3004785967-2020-01341
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2020

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: 10/19/2020
• Initial Date FDA Received: 11/09/2020
• 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): Required Intervention
• Patient Age: 24 YR