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 report with the FDA on 2018-10-03 for IN SITU ROD BENDER, STRAIGHT (DIA. 3.8MM) 07.01773.002 manufactured by Zimmer Biomet Spine Inc..

Event Text Entries

[122504892] 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


[122504893] It was reported that the tip of a rod bender was found to have broken off during a routine inspection. It is unknown how or when the device was being used when it broke.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012447612-2018-00791
MDR Report Key7930372
Report SourceDISTRIBUTOR
Date Received2018-10-03
Date of Report2019-01-21
Date of Event2018-09-05
Date Mfgr Received2019-01-16
Device Manufacturer Date2014-06-26
Date Added to Maude2018-10-03
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 Received2018-10-03
Returned To Mfg2018-09-13
Model NumberNA
Catalog Number07.01773.002
Lot Number62488146
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET SPINE INC.
Manufacturer Address10225 WESTMOOR DR. NA WESTMINSTER CO 80021 US 80021


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-03

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