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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Collapse (2416)
Event Type  Injury  
Manufacturer Narrative
(b)(6). (b)(4). Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore cause of event cannot be determined.
 
Event Description
Implant date: (b)(6) 2015 revision surgery: (b)(6) 2015 it was reported that on (b)(6) 2015, patient underwent vertebroplasty (vp) with postpericardiotomy syndrome (pps) at l1-l5 for compression at l3. Post-op, vertebral collapse was developed at l3. The surgeon commented patient's bone is very weak and anterior of l3 vertebral body was instable so the surgeon decided to add posterior lumbar fusion (plf) surgery and crosslink at revision surgery.
 
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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
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5359896
MDR Text Key35634108
Report Number1030489-2016-00148
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/12/2016 Patient Sequence Number: 1
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