FDA.reportPublic FDA data

MAUDE MDR 9862602

MDR report key
9862602
Report number
2939274-2020-01441
Event key
0
Event type
3
Date of event
2020-02-24
Date received
2020-03-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KARA DITTY-BOVARD
Address
1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US
Phone
610-610-6103
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT - STERILEPOLYMETHYLMETHACRYLATE (PMMA) BONE CEMENTWRIGHTS LANE SYNTHES USA PRODUCTS LLCLOD07.702.040S07.702.040S9J53310N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-200

Event Narratives#

N

Patient 1

THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

D

Patient 1

IT WAS REPORTED THAT ON FEBRUARY 24, 2020, THE TRAUMACEM V+ INJECTABLE BONE CEMENT MIXTURE PRODUCED ONLY ABOUT 4 MILLILITERS OF CEMENT SO THE SCRUB TECH WAS ONLY ABLE TO FILL THE FEW WHITE CANNULA OF CEMENT AND THERE WAS NO CEMENT LEFT. THERE WAS MORE CEMENT PUSH BURIED HARD ON THE CEMENT MIXTURE AND BROKE IT. THEY DISASSEMBLED THE CEMENT MIXTURE AND FOUND OUT THAT THERE WAS NOT ENOUGH CEMENT TO FILL ANOTHER ONE OF THE BLUE CANNULAS. THERE WAS A SURGICAL DELAY OF APPROXIMATELY TWO (2) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).