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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 5432141
Device Problem Device Inoperable (1663)
Patient Problem No Information (3190)
Event Date 06/03/2014
Event Type  malfunction  
Event Description
It was reported that the patient underwent a posterior spinal surgical procedure at l2-4.It was reported that two years post-op, the patient underwent a removal surgery.It was reported that the crosslink midline nut stripped during removal and was unable to be loosened.The crosslink was cut and removed.No patient complications were reported.
 
Manufacturer Narrative
(b)(4): neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
 
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Brand Name
CD HORIZON SPINAL SYSTEM
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
huzefa mamoola
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key3905106
MDR Text Key4515782
Report Number1030489-2014-02983
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/03/2014
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 Expiration Date03/08/2020
Device Catalogue Number5432141
Device Lot Number0205274W
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/03/2014
Initial Date FDA Received07/01/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/28/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
RODS
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