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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA VOYAGER SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA VOYAGER SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 54750017540
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Necrosis (1971); No Code Available (3191)
Event Date 03/28/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4) (revision surgery). Neither the device nor applicable imaging films were returned to manufacturer therefore cause of event cannot be determined. 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.

 
Event Description

It was reported that on (b)(6) 2016 (date is approx. ), post-op, l4 burst fracture was observed after 3+3 fixation. The rod was deviated at rear because (3 vertebral body) total six screws at cranial side were dislocated at rear. Six screws at caudal side ((b)(6)) from diseased vertebral l4 did not loosen so the surgeon did not perform screw reinsertion. Necrosis was found at l1 the most cranial side and the surgeon performed only cleaning without screw reinsertion. 4 screws ((b)(6)) were reinserted instead of l2((b)(6)) and l3((b)(6)) also 190 mm rod was placed at right and 180 mm rod was placed at left in the patient. The cause of dislocated screw was that patient bone quality was not good so there was no fixed power in the bone. At the surgery, the surgeon performed to open the incision in minimum due to necrosis. Also surgeon aimed at sufficient fixing force reinforcement with ha stick after removing screws.

 
Manufacturer Narrative

X-ray review: "post-op x-rays from stabilization of a lumbar deformity show screw pull out at multiple levels above fracture. There is lumbar kyphotic deformity, bone quality is poor. Instrumentation appears undersized, and the rod contour appears wrong, possibly contributing to pre load on screws. Root cause surgical technique and patient factors. " 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.

 
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Brand NameCD HORIZON SOLERA VOYAGER SPINAL SYSTEM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer (Section G)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5619154
MDR Text Key43983413
Report Number1030489-2016-01216
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK143375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/24/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number54750017540
Device LOT NumberH5208781
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 Received05/24/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/20/2015
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: 04/29/2016 Patient Sequence Number: 1
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