MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Device Problem Break (1069)

Patient Problems Death (1802); Dyspnea (1816); Pain (1994)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).(patient).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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported via medwatch form (mw5078098) that on (b)(6) 2017 , post-op, the patient experienced pain and it was diagnosed through x-ray that the rods were broken into 2 pieces.A revision surgery was performed to remove and replace the rods.But the rods were partially replaced in the surgery.Again the rods that were left in the first surgery broke at 3 places and it was confirmed through x-ray.The patient started having extreme pain and had breathing problems from the extreme crook at the back.The patient tried numbing himself mentally on not thinking about third surgery and then passed away in 2018.No further information has been provided.

Manufacturer Narrative

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

• Brand Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7766443
• MDR Text Key: 116528314
• Report Number: 1030489-2018-01111
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• 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
• Patient Outcome(s): Other; Required Intervention