I-FACTOR PEPTIDE ENHANCED BONE GRAFT 700-050

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-11-14 for I-FACTOR PEPTIDE ENHANCED BONE GRAFT 700-050 manufactured by Cerapedics, Inc..

MAUDE Entry Details

Report Number3007155473-2019-00014
MDR Report Key9321330
Report SourceDISTRIBUTOR
Date Received2019-11-14
Date of Report2019-11-12
Date of Event2018-11-15
Date Mfgr Received2018-12-10
Device Manufacturer Date2018-09-28
Date Added to Maude2019-11-14
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 ContactMR. MARK BOWERMAN
Manufacturer Street11025 DOVER ST. SUITE #1600
Manufacturer CityWESTMINSTER CO 80021
Manufacturer CountryUS
Manufacturer Postal80021
Manufacturer Phone3039746275
Manufacturer G1CERAPEDICS, INC.
Manufacturer Street11025 DOVER ST. SUITE #1600
Manufacturer CityWESTMINSTER CO 80021
Manufacturer CountryUS
Manufacturer Postal Code80021
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameI-FACTOR PEPTIDE ENHANCED BONE GRAFT
Generic NameBONE GRAFT
Product CodeNOX
Date Received2019-11-14
Model Number700-050
Catalog Number700-050
Lot Number18C0493
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCERAPEDICS, INC.
Manufacturer Address11025 DOVER ST. SUITE 1600 WESTMINSTER CO 80021 US 80021


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-11-14

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