SPINALPAK ASSEMBLY N/A 1067716

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-27 for SPINALPAK ASSEMBLY N/A 1067716 manufactured by Ebi, Llc..

MAUDE Entry Details

Report Number0002242816-2020-00022
MDR Report Key9763425
Report SourceCONSUMER
Date Received2020-02-27
Date of Report2020-02-24
Date Mfgr Received2020-02-05
Date Added to Maude2020-02-27
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 ContactSARA DAILEY
Manufacturer Street399 JEFFERSON ROAD
Manufacturer CityPARSIPPANY NJ 07054
Manufacturer CountryUS
Manufacturer Postal07054
Manufacturer Phone9732999300
Manufacturer G1EBI, LLC.
Manufacturer Street399 JEFFERSON ROAD
Manufacturer CityPARSIPPANY NJ 07054
Manufacturer CountryUS
Manufacturer Postal Code07054
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameSPINALPAK ASSEMBLY
Generic NameNON-INVASIVE, BONE GROWTH, STIMULATOR
Product CodeLOF
Date Received2020-02-27
Model NumberN/A
Catalog Number1067716
Lot NumberN/A
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEBI, LLC.
Manufacturer Address399 JEFFERSON ROAD PARSIPPANY NJ 07054 US 07054


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-27

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