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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK APPLIANCE, FIXATION, SPINAL INTERLAMINAL

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MEDTRONIC SOFAMOR DANEK APPLIANCE, FIXATION, SPINAL INTERLAMINAL Back to Search Results
Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)
Patient Problem Paralysis (1997)
Event Type  Injury  
Manufacturer Narrative
Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the cervical surgery, the patient experienced a serious complication as the cage touched the spinal cord.As a result, the patient suffered paralysis.A revision surgery was performed to correct the malpositioned cage.However, the revision surgery did not mitigate the complication.The product came in contact with the patient.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Type of Device
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
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
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key7672664
MDR Text Key113511991
Report Number1030489-2018-00970
Device Sequence Number1
Product Code KWP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/12/2018
Initial Date FDA Received07/10/2018
Supplement Dates Manufacturer Received08/08/2018
Supplement Dates FDA Received10/04/2018
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 Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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