FDA.reportPublic FDA data

MAUDE MDR 5548289

MDR report key
5548289
Report number
3006396387-2016-00003
Event key
0
Event type
3
Date of event
2016-03-09
Date received
2016-04-05
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 95131 US
Phone
408-408-4083
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1POWERCURVE NAVIGATING OSTEOTOMEOSTEOTOMEDFINE INCORPORATEDGFI2003-01PWR-2011LM210806Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-04-050

Event Narratives#

N

Patient 1

THE DEVICE WAS RECEIVED WITHIN THE FACILITY BUT HAS NOT BEEN EVALUATED. AS SOON AS THE FINAL ANALYSIS IS CONDUCTED, A SUPPLEMENTAL REPORT IS GOING TO BE FILED WITH THE RESULTS.

D

Patient 1

PER RECEIVED REPORT: CEMENT WAS INJECTED INTO THE VERTEBRAE. HOWEVER, IT DID NOT GO ACROSS MIDLINE SO THE PHYSICIAN REINSERTED THE POWERCURVE DEVICE. THE DEVICE WAS FULLY ARTICULATED REACHING ACROSS THE MIDLINE WITH SOME RESISTANCE SO THE PHYSICIAN TAPPED IN THE PROXIMAL END WITH A SMALL MALLET. ONCE FULLY DEPLOYED, THE PHYSICIAN TRIED TO REMOVE THE DEVICE BUT IT WAS STUCK IN THE HARD BONE. AFTER A FEW MINUTES AND SEVERAL ATTEMPTS TO DISLODGE THE DEVICE, THE DEVICE BROKE LEAVING THE DISTAL TIP IN THE PATIENT'S VERTEBRAL BODY. THE PIECE WAS IN THE MIDDLE OF THE VERTEBRAL BODY AND WAS NOT STICKING OUT AT ANY POINT, INCLUDING THE PEDICLE. THERE WAS NO METAL IN THE SOFT TISSUE, ALL WAS ENCASED IN THE BONE AND WAS AUGMENTED BY CEMENT. THERE WAS NO PATIENT INJURY REPORTED.

N

Patient 1

THE DEVICE WAS RECEIVED AND EVALUATED. UPON RECEIPT, VISUAL INSPECTION REVEALED TRACES OF BLOOD ON THE HANDLE AND SHAFT. PART OF THE ARTICULATING PORTION OF THE SHAFT HAD BROKEN OFF OF THE DEVICE. THE LENGTH OF THE DEVICE WAS APPROXIMATELY 15 CM, MEANING APPROXIMATELY 2 CM OF THE TIP HAD BROKEN OFF. UNDER MAGNIFICATION, LONGITUDINAL CUTS ALONG THE LASER CUTS WERE NOTED WHICH CONSTITUTED THE BREAKAGE. THE BREAKAGE APPEARED TO BE A DUCTILE FRACTURE, OCCURRING AT THE POINT OF THE LASER CUTS DESIGNED FOR ARTICULATION. THE CUSTOMER REPORTED EVENT OF THE TIP OF THE POWER CURVE (TRADEMARK) 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 DEFINITE 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.