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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK SHILLA GROWTH GUIDANCE SYSTEM
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MEDTRONIC SOFAMOR DANEK SHILLA GROWTH GUIDANCE SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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.
 
Event Description
It was reported that 33 patients underwent unspecified instrumentation surgery, for the treatment of early-onset scoliosis (neuromuscular, idiopathic, congenital, syndromic).Post-operatively, five patients had complications with wound breakdown requiring a return to the operating room.No further information was provided.
 
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Brand Name
SHILLA GROWTH GUIDANCE SYSTEM
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 Key6002405
MDR Text Key56538678
Report Number1030489-2016-02782
Device Sequence Number1
Product Code PGM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation Health Professional
Type of Report Initial
Report Date 09/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2016
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? Yes
Date Manufacturer Received09/06/2016
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 N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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