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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 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 7578301
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/03/2017
Event Type  malfunction  
Manufacturer Narrative
Product analysis: it is possible that with excessive force the extender could be popped off the head. During normal use, the extenders would appear to function properly. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that patient underwent transforaminal lumbar interbody fusion (tlif) with posterior fixation. During surgery, there was an audible pop sound and the tower came off. The screw and the tower at l5 were then replaced with new ones. Then both the persuaders were reduced down to 4mm. The s1 set screws were engaged but the l5 set screw would not engage so persuader was reduced to just a 1 mm more and this is when the tower popped off of the screw again, but just on one side. At this point, the l5 screw was switched, tlif was completed and screws and a rod were put on the patients left side with no further issues. The product came in contact with the patient. No patient complications were reported as the result of the event.
 
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Brand NameCD HORIZON 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 Key7439118
MDR Text Key105769634
Report Number1030489-2018-00569
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00643169177048
UDI-Public00643169177048
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122862
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7578301
Device Lot NumberEM15G033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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