COMPOSITE SCREW LIGAFIX 60 DIAM. 8 - L:25 MM COM6008025

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-23 for COMPOSITE SCREW LIGAFIX 60 DIAM. 8 - L:25 MM COM6008025 manufactured by S.b.m. Sas.

MAUDE Entry Details

Report Number3004549189-2020-00003
MDR Report Key9864693
Report SourceDISTRIBUTOR
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2019-11-06
Date Mfgr Received2019-11-08
Device Manufacturer Date2013-12-08
Date Added to Maude2020-03-23
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 ContactMS. REGINE BAREILLES
Manufacturer StreetZI DU MONGE
Manufacturer CityLOURDES, FRANCE 65100
Manufacturer CountryFR
Manufacturer Postal65100
Manufacturer G1S.B.M. SAS
Manufacturer StreetZI DU MONGE
Manufacturer CityLOURDES, FRANCE 65100
Manufacturer CountryFR
Manufacturer Postal Code65100
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMPOSITE SCREW LIGAFIX 60 DIAM. 8 - L:25 MM
Generic NameINTERFERENCE SCREW
Product CodeMAI
Date Received2020-03-23
Returned To Mfg2019-12-02
Catalog NumberCOM6008025
Lot Number183723
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerS.B.M. SAS
Manufacturer AddressZI DU MONGE LOURDES, FRANCE 65100 FR 65100


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-23

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