SPEED DRILL KIT WITH 2.65MM DRILL BIT DK-265

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 2020-01-30 for SPEED DRILL KIT WITH 2.65MM DRILL BIT DK-265 manufactured by Oberdorf Synthes Produktions Gmbh.

MAUDE Entry Details

Report Number8030965-2020-00727
MDR Report Key9648994
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-30
Date of Report2020-01-08
Date of Event2020-01-07
Date Mfgr Received2020-02-03
Device Manufacturer Date2017-07-13
Date Added to Maude2020-01-30
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 ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHT LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6107195000
Manufacturer G1SYNTHES BME : SAN ANTONIO
Manufacturer Street14785 OMICRON DRIVE #205
Manufacturer CitySAN ANTONIO TX 78245
Manufacturer CountryUS
Manufacturer Postal Code78245
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPEED DRILL KIT WITH 2.65MM DRILL BIT
Generic NameSTAPLE, FIXATION, BONE
Product CodeJDR
Date Received2020-01-30
Model NumberDK-265
Catalog NumberDK-265
Lot NumberBDK170399
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOBERDORF SYNTHES PRODUKTIONS GMBH
Manufacturer AddressEIMATTSTRASSE 3 OBERDORF 4436 SZ 4436


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-30

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