FDA.reportPublic FDA data

MAUDE MDR 4798153

MDR report key
4798153
Report number
3006396387-2015-00005
Event key
0
Event type
3
Date of event
2015-04-22
Date received
2015-05-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
ROBERT FOUNDS
Address
3047 ORCHARD PARKWAY SAN JOSE CA 95134 US
Phone
408-408-4083
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VERTECOR MIDLINE CEMENT STAGING OSTEOTOMEOSTEOTOMEDFINE INC.GFINA0987M209037Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-05-190

Event Narratives#

D

Patient 1

AFTER 3 PASSES THE MIDLINE OSTEOTOME BECAME STUCK IN HARD SCLEROTIC BONE DURING CAVITY CREATION AND WAS NOT ABLE TO BE REMOVED. AFTER REPEATED ATTEMPTS TO TRY TO REMOVE THE DEVICE, THE OUTER SLEEVE OF THE MIDLINE OSTEOTOME BROKE OFF AND REMAINED IN THE PATIENT'S VERTEBRAL BODY AND PEDICLE.

N

Patient 1

A REVIEW OF THE MATERIAL SPECIFICATIONS (B)(4), THE MATERIAL OF THE VERTECOR MIDLINE OSTEOTOME 3.0, PN3765 CONFIRMED THAT THE TIP OF THE DEVICE IS MADE FROM MEDICAL GRADE 316 STAINLESS STEEL; SIMILAR TO PEDICLE SCREWS, COMMONLY USED AS PERMANENT IMPLANTS IN FUSION SPINE SURGERY.