MICROCHOICE INTRA ORAL BLADE 11.5X7 X 4MM 00502310100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-06-05 for MICROCHOICE INTRA ORAL BLADE 11.5X7 X 4MM 00502310100 manufactured by Conmed Linvatec.

Event Text Entries

[21609677] It was reported that during use of this blade in an intraoral vertical ramus osteotomy, the blade broke in the patient's bone and was retrieved. There was no injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5


[21798449] Investigation findings: the blade was received for evaluation without the detached portion. A visual inspection confirmed the reported problem and found the blade broke off at the shaft weld. The investigation was unable to determine a cause for this failure. A review of product history for the past 2 years shows one similar reported problem. No injuries are associated with this failure mode. Conmed linvatec will continue to monitor this product for failures.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1017294-2007-00312
MDR Report Key863700
Report Source06
Date Received2007-06-05
Date of Report2007-05-10
Date of Event2007-05-10
Date Mfgr Received2007-05-10
Device Manufacturer Date2006-11-02
Date Added to Maude2007-07-16
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 FDA0
Event Location0
Manufacturer ContactBEVERLY SCHANER
Manufacturer Street11311 CONCEPT BLVD.
Manufacturer CityLARGO FL 33773
Manufacturer CountryUS
Manufacturer Postal33773
Manufacturer Phone7273995169
Manufacturer G1CONMED LINVATEC
Manufacturer Street11311 CONCEPT BLVD.
Manufacturer CityLARGO FL 33773
Manufacturer CountryUS
Manufacturer Postal Code33773
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMICROCHOICE INTRA ORAL BLADE 11.5X7 X 4MM
Generic NameSTERILE BLADE
Product CodeDZH
Date Received2007-06-05
Returned To Mfg2007-05-23
Model NumberNA
Catalog Number00502310100
Lot NumberBBC78398
ID NumberNA
Device Expiration Date2011-11-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key858867
ManufacturerCONMED LINVATEC
Manufacturer AddressLARGO FL US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-06-05

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