FDA.reportPublic FDA data

MAUDE MDR 9664200

MDR report key
9664200
Report number
0002242816-2020-00015
Event key
0
Event type
3
Date received
2020-02-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
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
1BIOMET EBI BONE HEALING SYSTEMSTIMULATOR, BONE GROWTH, NON-INVASIVEEBI, LLC.LOFN/A1068234N/AR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-0401. 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 WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE DEVICE IS STILL BEING USED. THE INVESTIGATION IS IN PROCESS. 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 BONE HEALING SYSTEM (BHS). THE PATIENT GOT THE BHS FOR HER RIGHT FOOT. THE PATIENT STATED THAT THE PAIN FELT LIKE AN INTENSE THROBBING. THE PATIENT RATED THE PAIN A 9 OR 10 ON A SCALE OF 1 TO 10, WITH 10 BEING THE WORST. THE PATIENT STATED THAT THE PAIN WAS THE MOST INTENSE WHILE SHE SLEPT; IT WOULD WAKE HER OUT OF HER SLEEP. WHEN THE PATIENT WEARS THE BHS DURING THE DAY THE PAIN IS NO WHERE NEAR AS INTENSE AS WHEN SHE SLEEPS. THERE ARE NO MARKS ON HER SKIN. THE PATIENT DID SPEAK TO HER DOCTOR WHO SAID THAT THEY HAD NEVER HEARD ANYTHING LIKE THIS BEFORE. THE PATIENT IS NOW WEARING THE DEVICE ONLY DURING THE DAY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.