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U.S. Department of Health and Human Services

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

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MEDTRONIC SOFAMOR DANEK USA, INC. CD HORIZON SPINAL SYSTEM Back to Search Results
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.
 
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Brand NameCD 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 Key9683827
MDR Text Key178327329
Report Number1030489-2020-00156
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
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 Received02/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2020
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 Treatment Data
Date Received: 02/07/2020 Patient Sequence Number: 1
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