FDA.reportPublic FDA data

MAUDE MDR 4993201

MDR report key
4993201
Report number
3006396387-2015-00010
Event key
0
Event type
3
Date of event
2015-07-09
Date received
2015-07-31
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
DAN BALBIERZ
Address
30478 ORCHARD PARKWAY SAN JOSE CA 95134 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VERTECOR MIDLINE CEMENT STAGING OSTEOTOMEOSTEOTOMEDFINE INC.GFINA1620150521Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-07-310

Event Narratives#

N

Patient 1

THE PRODUCT HAS NOT BEEN RECEIVED WITHIN OUR FACILITY FOR EVALUATION. UPON RECEIPT, FINAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

D

Patient 1

PER RECEIVED REPORT: DURING PROCEDURE, THE MIDLINE OSTEOTOME (MLO) WAS INSERTED AND MADE 1 (ONE) PASS. THE BONE WAS REPORTED TO HAVE NOT BEEN DENSE OR SCLEROTIC. THE MIDLINE OSTEOTOME WAS DIFFICULT TO REMOVE AND CAME OUT COMPLETELY BENT. THE PHYSICIAN DID NOT ATTEMPT TO MAKE ANOTHER PASS. ONE CHANNEL WAS MADE FOR CAVITY CREATION AND THE CEMENT WAS EVENTUALLY DELIVERED. THERE WAS NO PATIENT INJURY REPORTED.

N

Patient 1

THE CUSTOMER REPORTED EVENT OF THE MIDLINE OSTEOTOM (MLO) BEING DIFFICULT TO REMOVE AND CAME OUT COMPLETELY BENT COULD NOT BE CONFIRMED. HOWEVER, INVESTIGATION REVEALED THE TIP HAD A MINOR BEND WHICH IS SIMILAR TO DEVICES THAT ENCOUNTERED DENSE OR HARD BONE DURING USE. THE DEVICE'S DISTAL END IS FLEXIBLE, BENDING OUT OF STABILITY INTRODUCER DURING DEPLOYMENT. ALTHOUGH THE TIP SUSTAINED MINOR BEND, THE CONCENTRATION OF STRESS AT ITS BEND EXHIBITED ADEQUATE STRENGTH TO WITHSTAND INSERTION AND REMOVAL FROM CANCELLOUS BONE WHEN PLACED THROUGH AN INTRODUCER WITH NO BREAKAGE SUSTAINED UNDER FORCE. THE DEVICE WAS SAFELY WITHDRAWN. ALTHOUGH THERE DOES NOT APPEAR TO BE ANY INDICATION OF PRODUCT QUALITY DEFICIENCY, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE CANNOT BE DETERMINED. ALL UNITS ARE 100% INSPECTED AND TESTED FOR ITS FUNCTIONALITY DURING THE MANUFACTURING PROCESS AND ONLY PASSING UNITS ARE MOVED TO THE NEXT PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY THE MIDLINE OSTEOTOME'S INTEGRITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT.