IN SITU ROD BENDER, STRAIGHT (DIA. 3.8MM) 07.01773.002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-06-28 for IN SITU ROD BENDER, STRAIGHT (DIA. 3.8MM) 07.01773.002 manufactured by Zimmer Biomet Spine Inc..

Event Text Entries

[149549553] Udi number: ni. 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.
Patient Sequence No: 1, Text Type: N, H10


[149549594] It was reported that the tip of an in-situ rod bender broke while bending a rod during surgery. The procedure was completed using an alternative rod bender without reported patient impacts.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012447612-2019-00284
MDR Report Key8745306
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2019-06-28
Date of Report2019-06-28
Date of Event2019-06-05
Date Mfgr Received2019-06-05
Date Added to Maude2019-06-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. ASHLEY MCPHERSON
Manufacturer Street10225 WESTMOOR DR. NA
Manufacturer CityWESTMINSTER CO 80021
Manufacturer CountryUS
Manufacturer Postal80021
Manufacturer Phone3034437500
Manufacturer G1ZIMMER BIOMET SPINE INC.
Manufacturer Street10225 WESTMOOR DR. NA
Manufacturer CityWESTMINSTER CO 80021
Manufacturer CountryUS
Manufacturer Postal Code80021
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameIN SITU ROD BENDER, STRAIGHT (DIA. 3.8MM)
Generic NameBENDER
Product CodeHXW
Date Received2019-06-28
Model NumberNA
Catalog Number07.01773.002
Lot Number62947717
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET SPINE INC.
Manufacturer Address10225 WESTMOOR DR. NA WESTMINSTER CO 80021 US 80021


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-28

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