. 3.5MM TI STARDRIVE CORTEX . SCREW SELF-TAPPING 30MM 04.200.030S

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 2020-03-25 for . 3.5MM TI STARDRIVE CORTEX . SCREW SELF-TAPPING 30MM 04.200.030S manufactured by Oberdorf Synthes Produktions Gmbh.

MAUDE Entry Details

Report Number8030965-2020-02281
MDR Report Key9878435
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-25
Date of Report2020-02-27
Date Mfgr Received2020-02-27
Device Manufacturer Date2019-08-16
Date Added to Maude2020-03-25
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 ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1SYNTHES SELZACH
Manufacturer StreetBOHACKERWEG 5
Manufacturer CitySELZACH 2545
Manufacturer CountrySZ
Manufacturer Postal Code2545
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name. 3.5MM TI STARDRIVE CORTEX . SCREW SELF-TAPPING 30MM
Generic NamePLATE,FIXATION,BONE
Product CodeHRS
Date Received2020-03-25
Returned To Mfg2020-03-16
Catalog Number04.200.030S
Lot Number5L69636
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerOBERDORF SYNTHES PRODUKTIONS GMBH
Manufacturer AddressEIMATTSTRASSE 3 OBERDORF 4436 SZ 4436


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-25

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