EASY SPINE SCREW, UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-24 for EASY SPINE SCREW, UNKNOWN manufactured by Ldr Medical.

Event Text Entries

[187556338] Common device name: easy spine system or ldr spine usa spine tune, tl spinal system, ldr spine usa easy spine, posterior spinal system, ldr spine usa mc implant s... 510(k) number: k123134 or k121103. Without a product return, no product evaluation is able to be conducted. The lot number is unknown; therefore the device history records are unable to be reviewed. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent. Reference reports 3004788213-2020-00029 to 3004788213-2020-00034.
Patient Sequence No: 1, Text Type: N, H10


[187556339] It was reported that a patient underwent a revision surgery to remove an easy spine construct for an unknown reason. There was no further surgical or patient information provided. This is report three of six for this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004788213-2020-00031
MDR Report Key9876089
Report SourceDISTRIBUTOR,FOREIGN
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-02-07
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-24
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. FLORENCE MAILY
Manufacturer StreetQUARTIER EUROPE DE L 5, RUE DE BERLIN
Manufacturer CitySAINTE-SAVINE, NA 10300
Manufacturer CountryFR
Manufacturer Postal10300
Manufacturer Phone33382803
Manufacturer G1LDR MEDICAL
Manufacturer StreetQUARTIER EUROPE DE L 5, RUE DE BERLIN
Manufacturer CitySAINTE-SAVINE, NA 10300
Manufacturer CountryFR
Manufacturer Postal Code10300
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameEASY SPINE SCREW, UNKNOWN
Generic NameSEE H10
Product CodeNKB
Date Received2020-03-24
Model NumberNA
Catalog NumberNI
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLDR MEDICAL
Manufacturer AddressQUARTIER EUROPE DE L?OUEST 5, RUE DE BERLIN SAINTE-SAVINE, NA 10300 FR 10300


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-24

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