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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

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MEDTRONIC SOFAMOR DANEK CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL Back to Search Results
Catalog Number G75446545
Device Problem Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/04/2017
Event Type  Injury  
Manufacturer Narrative
This part is not approved for use in the united states; however a like device catalog # 75446545, 510k #k042025 was approved for sales in the united states.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.
 
Event Description
It was reported that the patient underwent posterior lumbar fusion (plf) at l4-5 due to lumbar canal stenosis.During the surgery, one pedicle screw that was inserted in the patient had deviated.This was found after the surgery was complete.The ct/mri indicated that the pedicle screw (ps) had backed out.The back-out was technical error.Hence, a revision surgery was performed on the same day in which it was explanted completely.The surgeon tried to insert the screw with changing angle of the screw, but the head of mas was completely locked and it could not be engaged with a screw driver.The screw was removed and replaced to the new one with changing the direction.There was a delay of less than 60 minutes in the overall procedure time.No patient complications were reported as a result of this.
 
Manufacturer Narrative
Additional information: product analysis- the screw was returned with the head locked.There are witness marks in the saddle of the screw indicating that the rod and the set screw had been locked into place.The witness marks do not line up with the cut out in the head, indicating the mas was loosened and re-tightened.This does not appear to be a failure of the mas as it appears to have performed to the design intent.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
CD HORIZON® SPINAL SYSTEM
Type of Device
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
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
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key6950750
MDR Text Key89360731
Report Number1030489-2017-02200
Device Sequence Number1
Product Code KWP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
SEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/01/2018
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
Device Catalogue NumberG75446545
Device Lot NumberH5313986
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/04/2017
Initial Date FDA Received10/16/2017
Supplement Dates Manufacturer Received03/08/2018
Supplement Dates FDA Received04/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2016
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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