SCREWDRIVER 5584111

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-21 for SCREWDRIVER 5584111 manufactured by Medtronic Sofamor Danek Usa, Inc.

Event Text Entries

[184442933] Product was not 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.
Patient Sequence No: 1, Text Type: N, H10


[184442954] It was reported that the patient presented with delayed paralysis after t12 compression fracture; and underwent posterior spinal fusion at t10-l2. Intra-op, screw head was slightly shaking when inserting the screw. The shaft of screw tip did not feel to be wobbling, but the head part seemed to draw an arc and it was uncomfortable to insert the screw. The screw and the driver were confirmed to be firmly gripped and locked before use. There were no patient complications reported as a result of this event. When checking the driver, it was found to be stripped at the tip of the shaft, deformed into a sleeve thread, and scratched at the handle connection.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1030489-2020-00347
MDR Report Key9863630
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-21
Date of Report2020-03-21
Date of Event2020-02-25
Date Mfgr Received2020-02-25
Device Manufacturer Date2018-05-18
Date Added to Maude2020-03-21
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 ContactSTACIE ZIEMBA
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal38132
Manufacturer Phone9013963133
Manufacturer G1MEDTRONIC SOFAMOR DANEK USA, INC
Manufacturer Street4340 SWINEA RD
Manufacturer CityMEMPHIS TN 38118
Manufacturer CountryUS
Manufacturer Postal Code38118
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSCREWDRIVER
Generic NameSCREWDRIVER
Product CodeHXX
Date Received2020-03-21
Model NumberNA
Catalog Number5584111
Lot NumberSW18D027
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC SOFAMOR DANEK USA, INC
Manufacturer Address4340 SWINEA RD MEMPHIS TN 38118 US 38118


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-21

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