BIOPLEX C IMPLANT 2002-121407

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2005-04-06 for BIOPLEX C IMPLANT 2002-121407 manufactured by Interpore Cross Intl..

Event Text Entries

[16275514] Surgeon reported that the implant cracked during surgery, however the implant did not break apart. Note: the surgeon opted to leave the implant in the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2029012-2005-00012
MDR Report Key589899
Report Source05,07
Date Received2005-04-06
Date of Report2005-03-29
Date of Event2005-01-10
Date Mfgr Received2005-01-13
Device Manufacturer Date2004-11-01
Date Added to Maude2005-04-12
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 Location0
Manufacturer ContactMARY CARVAJAL
Manufacturer Street181 TECHNOLOGY DR
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9494533200
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIOPLEX C IMPLANT
Generic NameCEMENT RESTRICTOR
Product CodeJDK
Date Received2005-04-06
Model NumberNA
Catalog Number2002-121407
Lot Number405811/405312
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagY
Date Removed*
Device Sequence No1
Device Event Key579748
ManufacturerINTERPORE CROSS INTL.
Manufacturer Address* IRVINE CA * US
Baseline Brand NameBIOPLEX IMPLANT
Baseline Generic NameCEMENT RESTRICTOR
Baseline Catalog No2002-121407
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]24
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK023908
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2005-04-06

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