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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
Model Number N/A
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2018
Event Type  Malfunction  
Manufacturer Narrative

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

It was reported that the patient underwent posterior spinal fusion(psf) in combination with balloon kyphoplasty (bkp) at l1/l3 due to l2 compression fracture. During the procedure, 4 small parts (convex part of the extender tip) inside the extender were worn. It seemed that the force of gripping a screw was weak. When pushing down the rod of l2 by sequential reducer, the extender deviated from the screw during rod tightening and became loose. Since the rod had almost been pushed down onto the screw head, it was not replaced, and the set screw was placed as it was and the operation was completed. A cross thread occurred when trying to provisionally fixing the set screw for the first time under condition of extender deviated. Washing was performed since there was metal piece. The extender was removed, and looked for the screw head directly to perform placement. This event occurred after bkp operation was performed at l2 and set screws were placed at l1 and l3. There was a delay of less than 60 minutes in procedure time due to this event. No patient complications were reported.

 
Manufacturer Narrative

Product analysis: the extender has visible signs of wear but would still function properly. If information is provided in the future, a supplemental report will be issued.

 
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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 Key8202402
MDR Text Key131592441
Report Number1030489-2018-01708
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK122862
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 03/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/28/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number7578302
Device LOT NumberEM15E022
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/13/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/07/2015
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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