• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC METRX SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC SOFAMOR DANEK USA, INC METRX SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 9561524
Device Problems Break (1069); Mechanics Altered (2984)
Patient Problem Hematoma (1884)
Event Date 09/28/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the healthcare provider (hcp) via the manufacturer representative regarding an event that occurred during an minimal invasive disc herniation procedure for a patient diagnosed with disc herniation.It was reported that the instrument broke and it did not retain the metrx tube.Patient had hematoma.No additional hospitalization was required, and no additional surgery/treatment was reported.Product return status is unknown, and it was replaced with a medtronic product.No other patient injury / complication was reported.
 
Manufacturer Narrative
D4: lot no.And udi no.Was updated.D9: return date was updated h6: codes are updated.H4: device manufacturing date was updated.H3: evaluation of the returned device was not completed at the time of this report.A follow up report will be sent when analysis is complete.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.
 
Manufacturer Narrative
H3: product analysis: 9561524 lot# my19m001 visual inspection revealed the flex arm was returned with no missing or disassembled components.Functional evaluation confirmed the handle was able to be tightened and loosened but the flex arm was not able to maintain the position once tightened.The internal locking mechanism seems to be worn from repeated use.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
METRX SYSTEM
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
MDR Report Key10732740
MDR Text Key213208081
Report Number1030489-2020-01480
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 04/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9561524
Device Catalogue Number9561524
Device Lot NumberMY19M001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2021
Date Manufacturer Received04/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-