AEQUALIS ASCEND FLEX REVERSED INSERT 36MM +9 12.5? DWF362B

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 2020-03-26 for AEQUALIS ASCEND FLEX REVERSED INSERT 36MM +9 12.5? DWF362B manufactured by .

Event Text Entries

[186559947] This is the final report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10


[186559948] It was reported that a patient had an acromial fracture (scapular spine stress fracture) not present pre-op, 1 year after primary surgery. Patient id: (b)(6)".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3000931034-2020-00038
MDR Report Key9882236
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-26
Date of Report2020-02-25
Date of Event2018-09-25
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-26
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 ContactMS MAUD ANDRIOLLO
Manufacturer Street161 RUE LAVOISIER
Manufacturer CityMONTBONNOT SAINT-MARTIN 38330
Manufacturer CountryFR
Manufacturer Postal38330
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAEQUALIS ASCEND FLEX REVERSED INSERT
Generic NameSHOULDER JOINT POLYMER PROSTHESIS
Product CodeKWS
Date Received2020-03-26
Model Number36MM +9 12.5?
Catalog NumberDWF362B
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-26

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