FDA.reportPublic FDA data

MAUDE MDR 4964035

MDR report key
4964035
Report number
3006396387-2015-00008
Event key
0
Event type
3
Date of event
2015-07-06
Date received
2015-07-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
DAN BALBIERZ
Address
3047 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 SAGING OSTEOTOMEOSTEOTOMEDFINE INC.GFINA1620TLM-1408-26Y R

Patients#

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

Event Narratives#

N

Patient 1

THE DEVICE HAS NOT BEEN RECEIVED WITHIN OUR FACILITY FOR EVALUATION. UPON RECEIPT OF THE UNIT, A FINAL ANALYSIS WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT IS GOING TO BE SUBMITTED.

D

Patient 1

PER RECEIVED REPORT: THE MIDLINE OSTEOTOME (MLO) WAS USED ON 2 LEVELS, L2 AND L3. IT BROKE AND WAS UNABLE TO ARTICULATE DURING USE IN THE SECOND LEVEL. THE ARTICULATING PORTION BECAME MISSHAPEN. THE PHYSICIAN HAD DIFFICULTY REMOVING THE MLO AND NEARLY LOST ACCESS. THE PHYSICIAN CHOSE TO DELIVER THE CEMENT WITHOUT THE DESIRED AMOUNT OF CAVITIES. HE ULTIMATELY WENT BIPEDICULAR. THE CASE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT INJURY REPORTED.

N

Patient 1

THE DEVICE HAS BEEN RECEIVED AND AN INVESTIGATION WAS CONDUCTED. THE CUSTOMER REPORTED EVENT OF THE DEVICE BEING BROKEN OR MISSHAPEN COULD NOT BE CONFIRMED AS NO KINK, BEND OR SLIGHT DEFORMATION WAS NOTED AT THE TIP OR ANY PART OF THE SHAFT OF THE DEVICE. THE TIP RETAINED ITS SHAPE AS FUNCTIONAL TESTING WAS PERFORMED. THE DEVICE WAS EXAMINED UNDER A MICROSCOPE UNDER 0.7X MAGNIFICATION AND THE UNIT DID NOT REVEAL ANY INDICATION OF ANY PART BEING BROKEN OR MISSHAPEN AS WHAT THE INITIAL REPORT HAD INDICATED. THE ARTICULATION PORTION OF THE DEVICE APPEARED NORMAL AND PASSED ALL FUNCTIONAL TESTING CRITERIA. ALTHOUGH THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE CANNOT BE DETERMINED. ALL UNITS ARE 100% VISUALLY INSPECTED AND TESTED FOR ITS FUNCTIONALITY DURING THE MANUFACTURING PROCESS. ONLY PASSING UNITS ARE MOVED TO THE NEXT PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY THE MIDLINE OSTEOTOME'S (MLO) 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.