SHILLA GROWTH GUIDANCE SYSTEM UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2016-10-06 for SHILLA GROWTH GUIDANCE SYSTEM UNK manufactured by Medtronic Sofamor Danek.

Event Text Entries

[56539075] 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.
Patient Sequence No: 1, Text Type: N, H10


[56539076] It was reported that 33 patients underwent unspecified instrumentation surgery, for the treatment of early-onset scoliosis (neuromuscular, idiopathic, congenital, syndromic). Post-operatively, rod prominence was observed in fourteen patients. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1030489-2016-02779
MDR Report Key6002392
Report SourceHEALTH PROFESSIONAL,LITERATUR
Date Received2016-10-06
Date of Report2016-09-06
Date Mfgr Received2016-09-06
Date Added to Maude2016-10-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactGREG ANGLIN
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal38132
Manufacturer Phone9013963133
Manufacturer G1MEDTRONIC SOFAMOR DANEK
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal Code38132
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSHILLA GROWTH GUIDANCE SYSTEM
Product CodePGM
Date Received2016-10-06
Model NumberNA
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC SOFAMOR DANEK
Manufacturer Address1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132


Patients

Patient NumberTreatmentOutcomeDate
10 2016-10-06

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