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 Bacterial Infection (1735); Necrosis (1971); Ambulation Difficulties (2544)

Event Date 08/17/2020

Event Type  Injury  

Manufacturer Narrative

Patient information was not included in the journal entry.The four patient's ages were (b)(6).The amount of each gender was even, so male was chosen as a place holder.There were two males and two females who underwent the internal hemipelvectomy.The article did not provide the date of the procedure.The event date provided is the accepted for publication date.The article citation is included.The system product number and serial number were not provided in the journal article.Udi not available for this system.No 510k provided as system is unknown.No evaluation was performed as the event was reported as a literature article.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: tepper sc, blank at, gitelis s, colman mw.Pelvic ring reconstruction with segmental spinal instrumentation after complete type i pelvic resection.J surg oncol.2020;122:1721¿1730.Summary: background and objectives: internal hemipelvectomy is a complex procedure used to treat malignancy that involves the pelvis.Reconst ruction of the pelvis after type i or type i/iv resection remains controversial due to high complication rates and debatable functional benefit.Modern reconstruction options may provide a rapid, intuitive, and reliable way to reconstitute the pelvic ring.Methods: this is a retrospective case series of four patients who underwent a novel reconstruction method involving computer navigation and segmental spinal instrumentation applied to the pelvis after type i or type i/iv pelvic resection for malignancy between 2015 and 2020.Results: time to ambulation postoperatively ranged from 1 to 7 days, and median length of hospital stay was 8.5 (7.5, 10.5) days.Complications included wound necrosis in two patients that did not require reoperation and wound infection in one patient that required irrigation and debridement.There was no radiographic evidence of hardware loosening or failure on follow-up.Three patients remain alive and two remain disease-free.Atmost recent follow-up, all patients were able to ambulate and perform activities of daily living.Conclusions: the technique for pelvic reconstruction described allows for rapid fixation intraoperatively with few complications and satisfactory functional results in this limited series.Reported: four patients with a history of osseous pelvic malignancy underwent internal hemipelvectomy.During the procedures all patient were exposed to the implantation of a pedicle screw, freehand.After the procedure, it took an average of 4.5 days for ambulation.Three patients were touch down weight bearing and one patient was 30% weight bearing.Three patients had postoperative wound complications.One patient had an area of wound necrosis at the distal aspect of the incision thatrequired multiple superficial debridement's in the plastic surgery clinic and daily dressing changes.This wound did not require re-irrigation and debridement with removal of the tibial allograft.Another patient had an area of wound necrosis that resolved with observation three weeks postoperatively.Finally, another patient had adequate wound healing, but developed persistent drainage from the posterior aspect of the surgical incision six weeks postoperatively.The patient was taken to the operating room for irrigation and debridement with removal of the tibial allograft.Intraoperative cultures grew staphylococcus aureus, and the patient was treated with six weeks of intravenous antibiotics w ith complete resolution of symptoms.One patient had a trendelenburg gait, but was ambulating with a single cane without difficulty.

Manufacturer Narrative

G4: the 510k number was added.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

G4: correction - no 510k provided as system is unknown.Previous 510k number submitted was incorrect.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 13335154
• MDR Text Key: 288477941
• Report Number: 3004785967-2022-00049
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151000
• 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,Followup,Followup
• Report Date: 01/11/2023

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: 01/07/2022
• Initial Date FDA Received: 01/24/2022
• Supplement Dates Manufacturer Received: 01/11/2023; 01/11/2023
• Supplement Dates FDA Received: 01/11/2023; 01/11/2023
• 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; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male