BIOSTOP G CEM RESTR 18MM 546318000

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 2019-08-30 for BIOSTOP G CEM RESTR 18MM 546318000 manufactured by Depuy Orthopaedics, Inc. 1818910.

MAUDE Entry Details

Report Number1818910-2019-102613
MDR Report Key8949493
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-08-30
Date of Report2019-08-09
Date of Event2019-08-06
Date Mfgr Received2019-11-07
Device Manufacturer Date2018-06-18
Date Added to Maude2019-08-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. KARA DITTY-BOVARD
Manufacturer Street1210 WARD AVENUE
Manufacturer CityWEST CHESTER IN 193800988
Manufacturer CountryUS
Manufacturer Postal193800988
Manufacturer Phone6103142063
Manufacturer G1DEPUY CMW - 9610921
Manufacturer StreetCORNFORD RD
Manufacturer CityBLACKPOOL FY4 4QQ
Manufacturer CountryUK
Manufacturer Postal CodeFY4 4QQ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIOSTOP G CEM RESTR 18MM
Generic NameDEPUY CMW RESORBABLE BIOMATERIALS : CEMENT CENTRALIZER/PLUG
Product CodeJDK
Date Received2019-08-30
Catalog Number546318000
Lot Number18C1501008
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-30

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