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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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MEDTRONIC SOFAMOR DANEK CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Device Problems Difficult to Remove (1528); Device Inoperable (1663)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/10/2014
Event Type  No Answer Provided  
Event Description
It was reported that the patient underwent a posterior spinal surgical procedure at t10-l3.It was reported that a crosslink was implanted and found to be too high profile.The crosslink set screw stripped out during removal.The crosslink was cut out but a portion of the device was left attached to the rod and not removed from the patient.No additional patient complications were reported.
 
Manufacturer Narrative
(b)(4).Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
 
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Brand Name
CD HORIZON SPINAL SYSTEM
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
huzefa mamoola
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key3987450
MDR Text Key15112591
Report Number1030489-2014-03407
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/10/2014
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 Number1
Treatment
ROD, SCREW
Patient Outcome(s) Other;
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