SHILLA GROWTH GUIDANCE SYSTEM 7674500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-08-28 for SHILLA GROWTH GUIDANCE SYSTEM 7674500 manufactured by Medtronic Sofamor Danek Usa, Inc.

Event Text Entries

[4803318] It was reported that a patient underwent an unknown spinal surgery. It was reported that at an unknown time post-op, two rods were broken. Patient underwent revision surgery to replace the broken rods.
Patient Sequence No: 1, Text Type: D, B5


[12278275] (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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1030489-2014-03595
MDR Report Key4045211
Report Source01,05,07
Date Received2014-08-28
Date of Report2014-08-20
Date Mfgr Received2014-08-20
Date Added to Maude2014-08-29
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 FDA0
Event Location0
Manufacturer ContactHUZEFA MAMOOLA
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 Received2014-08-28
Catalog Number7674500
Lot NumberCA11D020
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC SOFAMOR DANEK USA, INC
Manufacturer Address4340 SWINEA RD MEMPHIS TN 38118 US 38118


Patients

Patient NumberTreatmentOutcomeDate
10 2014-08-28

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