FDA.reportPublic FDA data

MAUDE MDR 8607556

MDR report key
8607556
Report number
3012447612-2019-00220
Event key
0
Event type
3
Date of event
2019-01-08
Date received
2019-05-14
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
MS. ASHLEY MCPHERSON
Address
10225 WESTMOOR DR. NA WESTMINSTER CO 80021 US
Phone
303-303-3034
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FRENCH ROD BENDERBENDERZIMMER BIOMET SPINE INC.HXWNA07.02092.00163028554Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-140

Event Narratives#

N

Patient 1

UDI NUMBER: (B)(4). THE RETURNED ROD BENDER WAS EVALUATED. THE SCREW THAT HOLDS THAT CENTRAL KNOB IN PLACE HAS DISASSEMBLED, PREVENTING THE DEVICE FROM BEING ABLE TO BEND A ROD. THE CAUSE IS LIKELY ATTRIBUTED TO REPETITIVE USAGE AND HIGH STRENGTH APPLICATIONS ASSOCIATED WITH BENDING COCR RODS. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. REFERENCE REPORT 3012447612-2019-00221.

D

Patient 1

IT WAS REPORTED THAT TWO FRENCH ROD BENDERS WERE STIFF DURING SURGERY. UPON EVALUATION AT ZIMMER BIOMET SPINE, ONE BENDER WAS FOUND TO BE MISSING A SET SCREW IN THE CENTER KNOB, AND THE OTHER HAS A BROKEN DOWEL PIN. ANOTHER ROD BENDER WAS USED TO COMPLETE THE PROCEDURE WITHOUT REPORTED PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.