MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. CD HORIZON SPINAL SYSTEM

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

Patient Problem Wound Dehiscence (1154)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Event date: only month and year valid.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.Although it is unknown whether the reported product caused or contributed to the reported event, we are filling this mdr for notific ation purpose.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that as per clinical study that the patient presented with deformity disease; and underwent open procedure at t11-t12, t12-l1, l1-l2, l2-l3, l3-l4, l4-l5 and l5-s1.On an unknown date in the month of jan 2020, post-op, the patient presented to emergency room due to incision wound dehiscence.This was a limited wound dehiscence, distal on incision, length of 1 cm and depth of 2 cm.Clinical examination and laboratory test for infection were performed.The investigator noted that the adverse event led to serious deterioration in the health of the patient that resulted in in-patient or prolonged hospitalization.The patient was hospitalized on (b)(6) 2020 but the period of hospitalization was not more than 24 hours.As a result of the reported adverse event, an additional surgical procedure was performed.Wound rinsing/debridement was performed with preservation of material.Secondary suture was done.Further local wound care at home was also done.According to the investigator, the adverse event was not related to the product but was related to the surgical procedure.The patient is reported to be recovering.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9683827
• MDR Text Key: 178327329
• Report Number: 1030489-2020-00156
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 71