FDA.reportPublic FDA data

MAUDE MDR 9606192

MDR report key
9606192
Report number
0002242816-2020-00008
Event key
0
Event type
3
Date received
2020-01-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
SARA DAILEY
Address
399 JEFFERSON ROAD PARSIPPANY NJ 07054 US
Phone
973-973-9732
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ORTHOPAK ASSEMBLYSTIMULATOR, BONE GROWTH, NON-INVASIVEEBI, LLC.LOFN/A1067718N/AY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-2001. R

Event Narratives#

N

Patient 1

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.

D

Patient 1

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.