CONFIDENCE KIT, NO NEEDLES 283913000

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 2020-01-24 for CONFIDENCE KIT, NO NEEDLES 283913000 manufactured by Medos International Sàrl Ch.

Event Text Entries

[176648986] Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[176648987] Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient was underwent an unknown surgery to stop the cement flow the pressure in the hydraulic pump is reduced by unscrewing the holder. While unscrewing the holder the inner thread got jammed. The inner piston got lifted out which resulted in the liquid to flow out. The inner piston was put back in place and complete the cement augmentation successfully. There were no fragments created. The surgery was delayed two minutes. There was no patient consequence. This is report 2 of 6 (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1526439-2020-00453
MDR Report Key9629188
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-24
Date of Report2020-01-10
Date of Event2020-01-10
Date Mfgr Received2020-03-02
Device Manufacturer Date2019-06-11
Date Added to Maude2020-01-24
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 StreetCHEMIN-BLANC 38
Manufacturer CityLE LOCLE 02400
Manufacturer CountrySZ
Manufacturer Postal02400
Manufacturer Phone6103142063
Manufacturer G1MEDOS INT SPINE
Manufacturer StreetCHEMIN BLANC 38
Manufacturer CityLE LOCLE 02400
Manufacturer CountrySZ
Manufacturer Postal Code02400
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONFIDENCE KIT, NO NEEDLES
Generic NamePOLYMETHYLMETHACRYLATE BONE CEMENT
Product CodeNDN
Date Received2020-01-24
Returned To Mfg2020-03-02
Model Number283913000
Catalog Number283913000
Lot Number244232
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDOS INTERNATIONAL SàRL CH
Manufacturer AddressCHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-24

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