PSI SD800.434 PEEK IMPLANT

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 2020-01-14 for PSI SD800.434 PEEK IMPLANT manufactured by Oberdorf Synthes Produktions Gmbh.

MAUDE Entry Details

Report Number8030965-2020-00358
MDR Report Key9587457
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-14
Date of Report2019-12-20
Date of Event2019-10-10
Date Mfgr Received2020-04-03
Device Manufacturer Date2019-09-06
Date Added to Maude2020-01-14
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 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1WERK MEZZOVICO (CH)
Manufacturer StreetVIA CAVAZZ 5
Manufacturer CityMEZZOVICO 6805
Manufacturer CountrySZ
Manufacturer Postal Code6805
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePSI SD800.434 PEEK IMPLANT
Generic NamePLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
Product CodeGXN
Date Received2020-01-14
Catalog NumberSD800.434
Lot Number6L04873
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
101. Required No Informationntervention 2020-01-14

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