SPEEDSHIFT COMPRESSION IMPLANT KIT 15X20MM OFFSET 6MM SE-1520-06

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-17 for SPEEDSHIFT COMPRESSION IMPLANT KIT 15X20MM OFFSET 6MM SE-1520-06 manufactured by Wrights Lane Synthes Usa Products Llc.

MAUDE Entry Details

Report Number2939274-2020-00262
MDR Report Key9601408
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-01-17
Date of Report2020-01-03
Date Mfgr Received2020-01-03
Device Manufacturer Date2017-12-08
Date Added to Maude2020-01-17
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
Manufacturer G1SYNTHES BME : SAN ANTONIO
Manufacturer Street14785 OMICRON DRIVE #205
Manufacturer CitySAN ANTONIO TX 78245
Manufacturer CountryUS
Manufacturer Postal Code78245
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPEEDSHIFT COMPRESSION IMPLANT KIT 15X20MM OFFSET 6MM
Generic NameBONE STAPLE
Product CodeJDR
Date Received2020-01-17
Returned To Mfg2018-06-18
Model NumberSE-1520-06
Catalog NumberSE-1520-06
Lot NumberBSE170807
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
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 2020-01-17

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