FDA.reportPublic FDA data

MAUDE MDR 7128153

MDR report key
7128153
Report number
MW5074094
Event key
0
Event type
3
Date of event
2017-05-17
Date received
2017-12-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WAX, BONEBONE WAXCP MEDICALMTJBW25GBW25G160414-58I *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-1801. O

Event Narratives#

D

Patient 1

DURING SURGERY, IT WAS REPORTED THAT THE PRODUCT HAD A BAD TEXTURE AND BAD SUPPORT IN THE BONE WITH DIFFICULT USE RESULTING TO AN ABSENCE OF HEMOSTATIC EFFECT. THERE WAS AN APPEARED OF A HEMATOMA AND ANOTHER SURGERY HAD BEEN NECESSARY TO RESOLVE THE CASE.