SILHOUETTE IC IMPLANT IITSS410D

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 2007-05-04 for SILHOUETTE IC IMPLANT IITSS410D manufactured by Biolok International Inc..

Event Text Entries

[627799] Implant did not integrate.
Patient Sequence No: 1, Text Type: D, B5


[7824059] Severity: minimal. Frequency: less than 2% of all implants manufactured. The implant does not appear to have been defective in any way.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1045056-2007-00036
MDR Report Key846263
Report Source05,07
Date Received2007-05-04
Date of Report2007-04-24
Date of Event2006-11-02
Date Facility Aware2006-11-02
Report Date2007-04-24
Date Reported to Mfgr2006-11-06
Date Mfgr Received2007-03-13
Device Manufacturer Date2005-06-01
Date Added to Maude2007-05-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street368 SOUTH MILITARY TRAIL
Manufacturer CityDEERFIELD BEACH FL 33442
Manufacturer CountryUS
Manufacturer Postal33442
Manufacturer Phone9546989998
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSILHOUETTE IC IMPLANT
Generic NameENDOSSEOUS IMPLANT
Product CodeDZS
Date Received2007-05-04
Returned To Mfg2006-11-06
Model NumberIITSS410D
Catalog NumberIITSS410D
Lot Number5718A-1
ID Number*
Device Expiration Date2011-07-01
OperatorOTHER
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key833383
ManufacturerBIOLOK INTERNATIONAL INC.
Manufacturer Address* DEERFIELD BEACH FL 33442 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2007-05-04

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