FDA.reportPublic FDA data

MAUDE MDR 5463887

MDR report key
5463887
Report number
3006396387-2016-00001
Event key
0
Event type
3
Date of event
2016-02-03
Date received
2016-02-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. DANIEL BALBIERZ
Address
3047 ORCHARD PARKWAY SAN JOSE CA 95134 US
Phone
408-408-4087
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1POWERCURVE NAVIGATING OSTEOTOMEOSTEOTOMEDFINE INCORPORATEDGFI4421PWL-1509-28Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-02-260

Event Narratives#

N

Patient 1

THE DEVICE IS IN THE PROCESS OF EVALUATION. AS SOON AS THE INVESTIGATION HAS BEEN CONDUCTED, A FINAL ANALYSIS REPORT REPORT WILL BE SUBMITTED.

D

Patient 1

THE PHYSICIAN WAS TREATING A PATIENT WITH A 3 TO 6 MONTH OLD BONE FRACTURE. THE BONE WAS DESCRIBED AS SIGNIFICANTLY DENSE AND SCLEROTIC. DURING THE PROCEDURE, A COUPLE OF CAVITIES WERE SUCCESSFULLY CREATED WHEN THE TIP OF THE POWERCURVE BROKE AND PART OF THE TIP WAS LEFT INSIDE THE VERTEBRAL BODY. THE PHYSICIAN DID NOT PERFORM ANY ADDITIONAL INTERVENTION TO REMOVE THE BROKEN PART. THE TIP REMAINED IN THE VERTEBRA AND WAS AUGMENTED BY CEMENT. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REPRESENTATIVE INDICATED THAT THE PROCEDURE WAS COMPLETED BY REMOVING AND REPLACING THE INTRODUCER AND WAS ABLE TO DELIVER THE CEMENT. APPROXIMATELY 2CM WAS LEFT IN THE VERTEBRAL BODY. THERE WAS NO PATIENT INJURY REPORTED.

N

Patient 1

WHEN RECEIVED, THE UNIT WAS NOT IN ITS ORIGINAL PACKAGING. TRACES OF BLOOD WERE OBSERVED ON THE HANDLE AND SHAFT OF THE DEVICE. INITIAL OBSERVATION REVEALED THAT PART OF THE ARTICULATING PORTION OF THE SHAFT HAD BROKEN OFF OF THE DEVICE. THE LENGTH OF THE DEVICE SHAFT UPON RECEIPT WAS APPROXIMATELY 14 CM, MEANING APPROXIMATELY 3 CM OF THE TIP HAD BROKEN OFF. UNDER MAGNIFICATION, THE BREAKAGE APPEARED TO BE A DUCTILE FRACTURE, OCCURRING AT THE POINT OF LASER CUTS DESIGNED FOR DEVICE ARTICULATION. THE UNIT WAS DISASSEMBLED. INVESTIGATION REVEALED SLIGHT DEFORMATION OF THE THREADS ON THE MALE THREAD ACTUATOR. NO ADDITIONAL DISCREPANCIES WITH OTHER COMPONENTS WERE NOTED. CONCLUSION: THE CUSTOMER REPORTED EVENT OF THE TIP OF THE POWER CURVE BREAKING, (LEAVING PART OF THE TIP INSIDE THE VERTEBRAL BODY) WAS CONFIRMED. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND A DEFINITIVE CAUSE FOR THE REPORTED ISSUE CANNOT BE DETERMINED. ALL UNITS ARE 100% VISUALLY INSPECTED AND TESTED FOR FUNCTIONALITY DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY THE DEVICE INTEGRITY.