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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 Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/09/2016
Event Type  malfunction  
Manufacturer Narrative
Device evaluation anticipated, but not yet begun.
 
Event Description
It was reported that the patient underwent posterior spinal fusion (1 above/1 below fusion for l2 burst fracture and 1 above/1 below fusion for l5 burst fracture).Reportedly, the surgeon and his team operated at l1/3 using the extender bodies with no problem.Following l1/3, when they operated at l4/5, reportedly, two extender bodies placed at sacrum came off during using the sequential reducer.The surgeon placed a rod under the patient's skin after he fixed at l5 (1a1b), l4 (sas) and s1 (mas).After that, connection of an extender and mas was deviated during pushing the rod using the sequential reducer.It happened at both side.There was an overall delay of less than 60 minute in the procedure.No patient complications were reported.Reportedly, post-op, it was found that grip part of the extender bodies did not move.
 
Manufacturer Narrative
Product analysis: visual and optical inspection identified plastic deformation on the extender mas head male interface features.The deformation of the interface features could have reduced the mechanical strength of the interface.The above observations are consistent with bend stress overload of the instruments.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.
 
Manufacturer Narrative
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
ORTHOSIS, 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 Key5626854
MDR Text Key44355205
Report Number1030489-2016-01274
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 Physician
Type of Report Initial,Followup,Followup
Report Date 06/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7578302
Device Lot NumberEM14M009
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/09/2016
Initial Date FDA Received05/03/2016
Supplement Dates Manufacturer ReceivedNot provided
06/09/2016
Supplement Dates FDA Received06/30/2016
09/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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