MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; RETRACTOR

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

Patient Problems Perforation (2001); Blood Loss (2597)

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Although it is unknown if the product contributed to the reported event, we are filing this mdr for notification purposes.If information is provided in the future, a supplemental report will be issued.

Event Description

Pre-operative diagnosis: leg pain type of procedure or technique used: alif (anterior lumbar interbody fusion) levels operated: l5/s1 it was reported via clinical study that intra-op, the patient experienced bleeding of the left commao iliac vein.The adverse event diagnosis stated iatrogen perforation of common iliac vein by retractor pin.As a result, an additional surgery was performed in the lumbar spine.According to the investigation, the adverse event was possibly related to general surgery, lumbar fusion procedure and minimally invasive procedure.The relatedness was also determined to be due to retractor pin.The event was resolved on (b)(6) 2018.

Manufacturer Narrative

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

Event Description

Date of termination/resolution of the adverse event changed to (b)(6) 2018 date of additional surgery in the lumbar spine: (b)(6) 2018 reason for this additional surgery: dorsale fusion l5/s1 relatedness of the adverse event changed to: not related to minimally invasive procedure.

Manufacturer Narrative

Additional information added 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.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.

Event Description

Updated information received on 23-mar-2022: ae outcome: terminated/resolved: 19-oct-2018.

• Type of Device: RETRACTOR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 8098662
• MDR Text Key: 128182184
• Report Number: 1030489-2018-01525
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 105 KG