ORTHOPAK ASSEMBLY N/A 1067718

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-20 for ORTHOPAK ASSEMBLY N/A 1067718 manufactured by Ebi, Llc..

Event Text Entries

[188860618] Zimmer biomet complaint (b)(4). Date of event: the event occurred sometime in (b)(6) 2019. The customer has indicated that the product is in the process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. The device has not been returned.
Patient Sequence No: 1, Text Type: N, H10


[188860619] It was reported that the patient was experiencing pain from using the orthopak assembly. The patient stated that the pain was very rare in the beginning but now the pain comes more often. It is a stabbing pain/ache. The patient does not believe that it is from the orthopak assembly but rather from the cold. The patient did reach out to her doctor and received a signed script for the patient to switch to a different device for treatment. No additional patient consequences have been reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002242816-2020-00008
MDR Report Key9606192
Report SourceHEALTH PROFESSIONAL
Date Received2020-01-20
Date of Report2020-03-30
Date Mfgr Received2020-03-18
Device Manufacturer Date2019-06-28
Date Added to Maude2020-01-20
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 NameORTHOPAK ASSEMBLY
Generic NameSTIMULATOR, BONE GROWTH, NON-INVASIVE
Product CodeLOF
Date Received2020-01-20
Returned To Mfg2020-03-16
Model NumberN/A
Catalog Number1067718
Lot NumberN/A
OperatorLAY USER/PATIENT
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerEBI, LLC.
Manufacturer Address399 JEFFERSON ROAD PARSIPPANY NJ 07054 US 07054


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.