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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® BALLAST¿ SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® BALLAST¿ SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 25740018590
Device Problems Migration or Expulsion of Device (1395); Device Slipped (1584)
Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Post Operative Wound Infection (2446)
Event Date 07/10/2018
Event Type  Injury  
Manufacturer Narrative
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 that the patient was pre-operatively diagnosed with kyphosis and underwent posterior fusion at l2/s2ai. Post-op, the wound opened due to some reasons after the operation , the patient underwent continuous cleaning. It was confirmed that the screw backed out when performing x-ray and ct. Since the wound was open and it was able to remove the product on the spot, revision fusion before wound closure was requested, so revision fusion was performed. Replacement was performed and the item was discarded. There was infection and the patient received re-operation several times. No patient complications were reported as the result of the event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameCD HORIZON® BALLAST¿ SPINAL SYSTEM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key7766751
MDR Text Key116528014
Report Number1030489-2018-01112
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00643169414921
UDI-Public00643169414921
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K153442
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number25740018590
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 Received08/08/2018
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

Patient Treatment Data
Date Received: 08/09/2018 Patient Sequence Number: 1
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