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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN MEDTRONIC IMPLANT
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MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN MEDTRONIC IMPLANT Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Type  Injury  
Event Description
It was reported on social media that a patient has had 4 back surgeries in the last 2 years.Per the post on the site, "her pain continues and the doctors were stumped until today.An x-ray showed an object under her skin in her back." the implant was removed and company's name was stamped on it.No other information was provided.
 
Manufacturer Narrative
(b)(4).Neither device nor images were returned.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
UNKNOWN MEDTRONIC IMPLANT
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
1800 pyramid place
memphis TN 38132
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 Key4532204
MDR Text Key5358074
Report Number1030489-2015-00339
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/22/2015
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 Sequence Number1
Patient Age00066 YR
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