PSI SD800.433 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,health report with the FDA on 2019-11-19 for PSI SD800.433 PEEK IMPLANT manufactured by Wrights Lane Synthes Usa Products Llc.

MAUDE Entry Details

Report Number2939274-2019-62292
MDR Report Key9343742
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-19
Date of Report2019-11-05
Date of Event2019-11-05
Date Mfgr Received2019-11-05
Date Added to Maude2019-11-19
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 PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1BRANDYWINE
Manufacturer Street1303 GOSHEN PARKWAY
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal Code19380
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePSI SD800.433 PEEK IMPLANT
Generic NamePLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
Product CodeGXN
Date Received2019-11-19
Model NumberSD800.433
Catalog NumberSD800.433
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWRIGHTS LANE SYNTHES USA PRODUCTS LLC
Manufacturer Address1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-19

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