MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UCSS; BIT, DRILL

Model Number 873-007

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/26/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via a field contact regarding a patient with a pre-operative diagnosis of at lantoaxial subluxation, undergoing a fusion procedure.It was reported that c1/2 fusion using infinity was scheduled from beginning, but the navigation was down, it was judged difficult to implement, so it was decided to use magerl method using ucss.On the left side of the first procedure, heavy bleeding occurred when drilling with the reported product.It was judged that the va was damaged, and the other side was given up.Mcgraw method was performed additionally and the operation was completed.There was a delay of less than 60 mins.Initial reporter information cannot be provided due to the restriction by the privacy regulation.The product will be returned and will not be replaced.Additional info received.It was reported that, after bleeding, compression hemostasis was performed.The amount of bleeding is unknown.Ct imaging was performed after the operation, and it was confirmed that va was okay.Doctors recognize that the drill itself is not defective/no malfunction and it's a technical factor.The patient issue was resolved.

Event Description

Information was received from a healthcare professional via a field contact regarding a patient with a pre-operative diagnosis of at lantoaxial subluxation, undergoing a fusion procedure.It was reported that c1/2 fusion using infinity was scheduled from beginning, but the navigation was down, it was judged difficult to implement, so it was decided to use magerl method using ucss.On the left side of the first procedure, heavy bleeding occurred when drilling with the reported product.It was judged that the va was damaged, and the other side was given up.Mcgraw method was performed additionally and the operation was completed.There was a delay of less than 60 mins.Initial reporter information cannot be provided due to the restriction by the privacy regulation.The product will be returned and will not be replaced.Additional info received.It was reported that, after bleeding, compression hemostasis was performed.The amount of bleeding is unknown.Ct imaging was performed after the operation, and it was confirmed that va was okay.Doctors recognize that the drill itself is not defective/no malfunction and it's a technical factor.The patient issue was resolved.Patient: (b)(6); female, 72 years old, 53kg.The product is not returning to memphis because the product itself has no defect and has been returned to a loaner.

Manufacturer Narrative

H2: additional information in b5.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: UCSS
• Type of Device: BIT, DRILL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 11018359
• MDR Text Key: 221717394
• Report Number: 1030489-2020-01805
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00673978067704
• UDI-Public: 00673978067704
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 873-007
• Device Catalogue Number: 873-007
• Device Lot Number: NG18L012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 53