ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 9560524

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 2020-03-28 for ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 9560524 manufactured by Medtronic Sofamor Danek Usa, Inc.

Event Text Entries

[186552371] 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


[186552372] It was reported that the patient underwent micro-endoscopic discectomy. Intra-op, the flex arm could not be fixed firmly even though the cable tightening wheel was turned. The product was continued to be used in the operation and the operation was finished. The sales rep had provided guidance for lubrication and draw-bar adjustment. No patient complications were reported as a result of this event. Upon checking the instrument, the handle screw of the flex arm was found to be worn near the thread center to the root.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1030489-2020-00393
MDR Report Key9894719
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-28
Date of Report2020-03-28
Date Mfgr Received2020-03-09
Device Manufacturer Date2019-08-14
Date Added to Maude2020-03-28
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 NameORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Generic NameORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Product CodeLXH
Date Received2020-03-28
Model NumberNA
Catalog Number9560524
Lot NumberMY19G001
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 2020-03-28

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