MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore cause of event cannot be determined.

Event Description

It was reported that the patient underwent plf at l3/5 with spinal system ten years ago.The surgeon left no comment regarding the surgery.Primary disease is adjacent vertebral disorder at l5/s.It was reported that patient underwent posterior fusion at l2-iliac (sai) and tlif surgery at l5/s on (b)(6) 2015.During surgery, surgeon tried to insert cage but height of the intervertebral was narrow so he could not insert it in the intervertebral after he removed intervertebral disc with shaver, curette and other products as usual.Cage inserter was loosened due to insertion.When the surgeon was hammering the cage at insertion, the part of the inserter that holds the cage got loosened but he went on to tighten the dial and then the part got broken.Cage which was lower height was placed instead and the surgery was completed.The surgery was extended less than 15mins.No patient complications were reported as a result of this event.

• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5359837
• MDR Text Key: 35991105
• Report Number: 1030489-2016-00147
• Device Sequence Number: 1
• Product Code: NEK
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 01/12/2016
• 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