FDA.reportPublic FDA data

MAUDE MDR 2882866

MDR report key
2882866
Report number
2520274-2012-04264
Event key
0
Event type
3
Date of event
2012-09-28
Date received
2012-12-20
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
KUBA ZAROBKIEWICZ
Address
1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US
Phone
800-800-8006
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WIRESYNTHES USADYXR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-12-2001. R

Event Narratives#

D

Patient 1

PATIENT HAD A TRIPLE CORONARY ARTERY BYPASS GRAFT PROCEDURE PERFORMED ON (B)(6) 2012. THE SAME DAY, AS THE PATIENT WAS STILL PRESENT AT THE HOSPITAL, THE PATIENT HEARD A POP SOUND AND NOTIFIED MEDICAL STAFF. IT WAS DETERMINED THAT THE PATIENT HAD OPENED BACK UP UNDERNEATH THE STAPLES. PATIENT WAS SLENDER IN SIZE. THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 AND THE FOUR ZIPFIX AND TWO DOUBLE WIRES THAT HAD BROKEN WERE REMOVED. THE SURGEON REVISED THE PATIENT WITH A COMBINATION OF SINGLE AND DOUBLE WIRES. THIS IS 6 OF 6 REPORTS FOR THIS EVENT.

N

Patient 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.