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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
Catalog Number 54740015545
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/25/2017
Event Type  malfunction  
Manufacturer Narrative
Product analysis: the head of the mas bone screw is splayed open slightly. This type of damage would have occurred because the set screw was misaligned. Once the splaying occurred the set screw would not torque down properly and could possibly jump threads. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
This part is not approved for use in the united states; however a like device catalog # 54840015545, 510k #k091974 and (b)(4) was cleared in the united states. Product was not 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
Pre-operative diagnosis :l1 burst fracture levels :t11-l2 it was reported that during surgery, there were metal fragments around the right side of l2 screw in the surgical field after final tightening. The screw head was widened due to cross thread, the screw was removed. There was a delay of less than 60 minutes in overall procedural time. No fragments of the screw were remaining in the patient. No patient complications were reported.
 
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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
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 Key7142102
MDR Text Key108349263
Report Number1030489-2017-02558
Device Sequence Number1
Product Code NKB
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
Type of Report Initial,Followup
Report Date 05/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/24/2020
Device Catalogue Number54740015545
Device Lot NumberH12A2197
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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