FDA.reportPublic FDA data

MAUDE MDR 1909906

MDR report key
1909906
Report number
1719045-2010-00339
Event key
0
Event type
3
Date of event
2010-10-28
Date received
2010-11-17
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
JODI TEMPLE
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
1CHISEL 10MMCHISELSYNTHES MONUMENTEMLNAPDL322NIR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-11-1701. R

Event Narratives#

D

Patient 1

DURING A PRODISC-L PROCEDURE AT L5-S1, THE SURGEON WAS USING THE CHISEL 10MM AND IT SPLIT THE VERTEBRAL BODY AND PUSHED A SMALL PIECE OF THE POSTERIOR CORTEX BACK IN TOWARDS THE SPINAL CORD. SURGEON PLACED THE PRODISC-L AND COMPLETED THE PROCEDURE. THE FOLLOWING DAY, THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR REMOVAL OF THE SMALL PIECE OF BONE. SURGEON INDICATED HE FELT THE EVENT WAS DUE TO A DULL CHISEL.

N

Patient 1

ADDITIONAL INFORMATION HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. MANUFACTURE DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER.