CLYDESDALE PTC SPINAL SYSTEM 4986050

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 2019-11-09 for CLYDESDALE PTC SPINAL SYSTEM 4986050 manufactured by Mdt Sofamor Danek Puerto Rico Mfg.

MAUDE Entry Details

Report Number1030489-2019-01294
MDR Report Key9301800
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-09
Date of Report2019-11-09
Date of Event2019-06-26
Date Mfgr Received2019-10-11
Date Added to Maude2019-11-09
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 G1MDT SOFAMOR DANEK PUERTO RICO MFG
Manufacturer StreetBARRIO MARIANNA RD 909, KM0.4
Manufacturer CityHUMACAO PR 00792
Manufacturer CountryUS
Manufacturer Postal Code00792
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLYDESDALE PTC SPINAL SYSTEM
Generic NameINTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Product CodeMAX
Date Received2019-11-09
Returned To Mfg2019-09-26
Model NumberNA
Catalog Number4986050
Lot NumberH5510808
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMDT SOFAMOR DANEK PUERTO RICO MFG
Manufacturer AddressBARRIO MARIANNA RD 909, KM0.4 HUMACAO PR 00792 US 00792


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-09

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