FDA.reportPublic FDA data

MAUDE MDR 6903605

MDR report key
6903605
Report number
0001825034-2017-07565
Event key
0
Event type
3
Date of event
2015-11-12
Date received
2017-09-29
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
MS. CHRISTINA ARNT
Address
56 E. BELL DR. WARSAW IN 46582 US
Phone
574-574-5745
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BONUS II-5CCALLOGRAFT BONEZIMMER BIOMET, INC.NUNN/A48-DBM5792060R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-290

Event Narratives#

N

Patient 1

REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF THE DHR FOUND THE PRODUCT WAS RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. (B)(4).

D

Patient 1

IT WAS REPORTED THAT DURING A CLAVICLE FRACTURE PROCEDURE THE BONUS DEMINERALIZED BONE MATRIX (DBM) WAS COMBINED WITH BONE MARROW CONCENTRATE (BMC), DBM DID NOT SOFTEN. THE SURGEON CRUSHED THE DBM AND SOAKED IT WITH THE BMC THAT WAS LEFT OVER. THE RESULTING MIXTURE WAS PUT INTO THE FRACTURE TO COMPLETE THE PROCEDURE.