FDA.reportPublic FDA data

MAUDE MDR 1576658

MDR report key
1576658
Report number
3004608878-2010-00001
Event key
0
Event type
3
Date of event
2009-12-29
Date received
2010-01-11
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
SUSAN SCOTT
Address
311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US
Phone
609-609-6099
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RADIAL IMPLANT, SMALL, LEFTUNI2 TOTAL WRIST IMPLANT SYSTEMINTEGRA LIFESCIENCES CORPORATION (INTEGRA OHIO)KWM263200LF1004532L10570R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-01-1101. R

Event Narratives#

D

Patient 1

THE REPORTED STATED THAT DURING A TOTAL WRIST IMPLANT PROCEDURE, THE PT'S RADIUS WAS REAMED READY TO ACCEPT THE RADIAL IMPLANT. WHEN THE SURGEON WAS SEATING PROSTHESIS INTO THE RADIUS, THE PT'S RADIUS FRACTURED AT THE TIP. THE RADIAL PROSTHESIS WAS REMOVED, AND A BURR WAS USED TO REAM OUT THE RADIAL CORTEX TO A LARGER SIZE. THE FRACTURE AROUND THE STEM OF THE PROSTHESIS WAS STABILIZED WITH A 2.7 DCP (DYNAMIC COMPRESSION PLATE); IT IS EXPECTED TO HEAL WELL. THE SURGEON STATED THAT THE DEVICE'S INSTRUCTION FOR USE OUGHT TO REFLECT THAT THE ACTUAL IMPLANT IS 2MM WIDER THAN THE TRIAL. THE SURGICAL PROCEDURE TOOK ABOUT ONE HOUR LONGER THAN IT WOULD IF THE RADIUS FRACTURE HAD NOT OCCURRED.

N

Patient 1

THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.