FDA.reportPublic FDA data

MAUDE MDR 7182882

MDR report key
7182882
Report number
0002242816-2018-00002
Event key
0
Event type
3
Date of event
2016-08-01
Date received
2018-01-11
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
MRS. MICHELLE COLE
Address
399 JEFFERSON ROAD PARSIPPANY NJ 07054 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SPF-XL IIB 2/DMSTIMULATOR, INVASIVE BONE GROWTHEBI, LLC.LOEN/A10-1335MN/AY N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-01-1101. H; 2. R

Event Narratives#

N

Patient 1

(B)(4). IF IMPLANTED, GIVE DATE: THE PRODUCT WAS IMPLANTED IN 2012; SPECIFIC DATE IS UNKNOWN. 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.

D

Patient 1

IT WAS REPORTED THE PATIENT COMPLAINED ABOUT THE STIMULATOR, THEREFORE A REVISION WAS PERFORMED DUE TO THE PATIENT'S WEIGHT LOSS WHICH CAUSED THE BONE STIMULATOR BATTERY TO MIGRATE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.