FDA.reportPublic FDA data

MAUDE MDR 405218

MDR report key
405218
Report number
1225520-2002-00002
Event key
0
Event type
3
Date of event
2002-04-17
Date received
2002-07-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JOHN BONASERA
Address
40 GRISSOM RD. SUITE 100 PLYMOUTH MA 02360 US
Phone
508-508-5087
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYMPHONY AND ACCESSORIESCENTRIFUGE (BLOOD PROCESS)HARVEST TECHNOLOGIESJQCSINGLE PROCESS KIT2760-40-101UNKNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-07-1501. R

Event Narratives#

D

Patient 1

PT'S LEFT TIBIA WAS REPAIRED (NON-UNION FRACTURE). ALLOMATRIX BONE GRAFT MATERIAL (WRIGHT MEDICAL AUTOLOGOUS PLATELET RICH PLASMA PREPARED WITH THE SYMPHONY SYSTEM WAS USED IN THE PROCEDURE WITH A REAM NAIL. THE INCISION BECAME INFECTED ONE WEEK POST-OPERATIVELY. THE PT WAS TREATED IN THE O.R. THE INCISION WAS DRAINED AND ANTIBIOTICS ADMINISTERED. DR. DID NOT BELIEVE THAT THE INFECTION WAS RELATED TO THE SYMPHONY (DEVICE) OR THE USE OF PRP. THE PROCESS DISPOSABLES THAT WERE USED TO PRODUCE THE PRP WERE DISCARDED AND THE LOT NUMBER IS UNKNOWN.