UNK - PLATES: SPINE

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 2019-11-04 for UNK - PLATES: SPINE manufactured by Oberdorf Synthes Produktions Gmbh.

MAUDE Entry Details

Report Number8030965-2019-68192
MDR Report Key9271970
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-04
Date of Report2019-08-16
Date Mfgr Received2019-08-16
Date Added to Maude2019-11-04
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 PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNK - PLATES: SPINE
Generic NameINTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
Product CodeODP
Date Received2019-11-04
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 2019-11-04

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