FDA.reportPublic FDA data

MAUDE MDR 8544892

MDR report key
8544892
Report number
3012447612-2019-00195
Event key
0
Event type
3
Date of event
2019-03-25
Date received
2019-04-24
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 BENDER (DIA. 3.5 MM - DIA. 3.8 MM)BENDERZIMMER BIOMET SPINE INC.HXWNA07.01770.00162732077Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-2401. O

Event Narratives#

N

Patient 1

CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

D

Patient 1

IT WAS REPORTED THAT A FRENCH ROD BENDER WOULD NOT BEND A ROD APPROPRIATELY DURING SURGERY. IN-SITU ROD BENDERS WERE USED TO BEND THE ROD TO COMPLETE THE PROCEDURE, BUT THIS LED TO A DELAY GREATER THAN 30 MINUTES LONG. THERE WERE NO REPORTED PATIENT IMPACTS ASSOCIATED WITH THE DELAY.

N

Patient 1

ADDITIONAL INFORMATION: (METHODS, RESULTS, AN CONCLUSIONS) - THE DEVICE WAS RETURNED AND EVALUATED. VISUAL INSPECTION REVEALED NO SIGNS OF DAMAGE. A FUNCTIONAL EXAMINATION SHOWED THE ROD BENDER WAS ABLE TO BEND A ROD WITHOUT ANY ISSUES. THE COMPLAINT IS UNCONFIRMED.

D

Patient 1

IT WAS REPORTED THAT A FRENCH ROD BENDER WOULD NOT BEND A ROD APPROPRIATELY DURING SURGERY. IN-SITU ROD BENDERS WERE USED TO BEND THE ROD TO COMPLETE THE PROCEDURE, BUT THIS LED TO A DELAY GREATER THAN 30 MINUTES LONG. THERE WERE NO REPORTED PATIENT IMPACTS ASSOCIATED WITH THE DELAY.