MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN MEDTRONIC ROD

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 11/26/2014

Event Type  Injury  

Event Description

A patient had undergone a tlif with a cage at l4 to l5.Back-out of the cage was revealed, leading to revision surgery at l3 to l5.The procedure included implanted rod removal with posterior approach and insertion of another cage following the removal of the original cage via olif.At the time of pulling the soft tissue with a punch, vessel was damaged causing haemorrhage.For persistent haemorrhage, vascular surgery department was consulted and under their guidance the procedure was completed.As a result of the incident, the surgical time was extended less than 15 minutes.

Manufacturer Narrative

(b)(4).The device was not returned to the manufacturer for evaluation; therefore, the cause of the event cannot be determined.

• Brand Name: UNKNOWN MEDTRONIC ROD
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4333878
• MDR Text Key: 5247055
• Report Number: 1030489-2014-04741
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/26/2014

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/26/2014
• Initial Date FDA Received: 12/16/2014
• Supplement Dates Manufacturer Received: 11/26/2014
• Supplement Dates FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CAGES
• Patient Outcome(s): Other
• Patient Age: 00038 YR