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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CD HORIZON SPINAL SYSTEM
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MEDTRONIC SOFAMOR DANEK CD HORIZON SPINAL SYSTEM Back to Search Results
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Code Available (3191)
Event Date 06/10/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient underwent a percutaneous pedicle screw procedure due to l3 burst fracture.During the surgery, extender was unable to be disengaged from screw after final tightening.A surgeon removed it barely from the screw.Post-op screw loosened.Screw replacement and fixation extension will be operated at s5.The product came in contact with the patient.There was a delay of less than 60 minutes in the overall procedure due to the event.
 
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Brand Name
CD HORIZON SPINAL SYSTEM
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
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5825334
MDR Text Key50516727
Report Number1030489-2016-02190
Device Sequence Number1
Product Code KWP
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 07/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 07/05/2016
Initial Date FDA Received07/27/2016
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
Patient Outcome(s) Required Intervention;
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