3.5MM TI CANCELLOUS POLYAXIAL SCREW 14MM 04.614.014

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 2020-03-11 for 3.5MM TI CANCELLOUS POLYAXIAL SCREW 14MM 04.614.014 manufactured by Oberdorf Synthes Produktions Gmbh.

MAUDE Entry Details

Report Number8030965-2020-01820
MDR Report Key9820697
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-11
Date of Report2020-02-13
Date of Event2020-02-14
Date Mfgr Received2020-02-13
Date Added to Maude2020-03-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter 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 G1MONUMENT
Manufacturer Street1101 SYNTHES AVENUE
Manufacturer CityMONUMENT CO 80132
Manufacturer CountryUS
Manufacturer Postal Code80132
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3.5MM TI CANCELLOUS POLYAXIAL SCREW 14MM
Generic NameORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
Product CodeNKG
Date Received2020-03-11
Catalog Number04.614.014
Lot Number29P0864
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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
101. Required No Informationntervention 2020-03-11

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