MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC

Model Number MSB_UNK_SCRW_SOLR

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Exsanguination (1841); No Known Impact Or Consequence To Patient (2692)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) via manufacturer representative for a patient diagnosed with l3/4 lumbar s pinal canal stenosis and underwent a l3/4 tlif.The patient had undergone a plf at l4/5 for the spondylolisthesis at l4 on (b)(6) 2013 and no medtronic product was involved in the procedure.During the revision surgery, it was reported that it deviated and there was bleeding.The procedure was completed with a delay of less than 60 mins.The event occurred on (b)(6) 2020, and it was notified to the manufacturer representative on the same day.Products return is requested, it will not be replaced with a medtronic product.No additional patient injury / complication is reported.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.B5.Event description added.H6: patient code was updated.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

Mdr decision corrected to not reportable since allegation pertaining to bleeding is not associated to this product involved in the event and no other patient injury / complication is reported.No additional supplemental report is required unless additional information received indicates reportable event.

• Brand Name: UNK
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10526917
• MDR Text Key: 206731252
• Report Number: 1030489-2020-01264
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• 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: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SCRW_SOLR
• Device Catalogue Number: MSB_UNK_SCRW_SOLR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR