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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
Catalog Number 7578302
Device Problems Break (1069); Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/02/2017
Event Type  malfunction  
Manufacturer Narrative
The product was not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
 
Event Description
It was reported that patient underwent posterior lumbar fusion at l2-s1. Intra-op, after creating of pilot hole, a screw was inserted using navigation at s1. The pilot hole was created smoothly with a probe but when the left screw at s1 was attached with extender and inserted,it was considered that the tip of the extender was touching inner wall of the ilium, so that a driver could not be tilted to lateral side. The surgeon stopped trying the insertion and started the insertion of other screws. The other screws were inserted without problem. To connect rods, the surgeon placed rod and inserted set screw but after final tightening, extender could not be removed. When the extender was removed after final tightening its tip was broken. No fragments left in the patient body. After the event, set screw was reinserted using rrp and final tightening was performed. No patient complications were reported.
 
Manufacturer Narrative
Product analysis :visual examination identified one of the associated component head gripper is detached from the instrument, with the separated component bent and fractured at the corner of the notch. The above observations are consistent with bend stress overload.
 
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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
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key6359913
MDR Text Key68354430
Report Number1030489-2017-00433
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K122862
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 04/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7578302
Device Lot NumberEM15C028
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/17/2015
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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