FDA.reportPublic FDA data

MAUDE MDR 9401021

MDR report key
9401021
Report number
0002242816-2019-00041
Event key
0
Event type
3
Date received
2019-12-03
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
12019-12-0301. R

Event Narratives#

N

Patient 1

(B)(4). DATE OF EVENT: THE EVENT OCCURRED SOMETIME IN (B)(6) 2019. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE HAS NOT BEEN RETURNED.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN FROM USING THE BONE HEALING SYSTEM. THE PATIENT WAS USING THE DEVICE FOR A TIBIAL FRACTURE NONUNION AND WAS EXPERIENCING PAIN IN HIS FOOT. THE PATIENT USED THE UNIT FOR ONE DAY. THE PATIENT SAW HIS PHYSICIAN AND WAS ADVISED TO STOP USING THE UNIT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.