VISE GRIPS 07.02104.001

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 2018-09-05 for VISE GRIPS 07.02104.001 manufactured by Zimmer Biomet Spine Inc..

Event Text Entries

[119346343] (b)(4). 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


[119346344] It was reported the screw of a vise grip fractured into two pieces during use. The pieces of the screw fell into the surgical incision but were removed. There was no adverse event to the patient or delay over 30 minutes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012447612-2018-00737
MDR Report Key7845792
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2018-09-05
Date of Report2018-12-26
Date of Event2018-07-24
Date Mfgr Received2018-12-17
Device Manufacturer Date2017-01-24
Date Added to Maude2018-09-05
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 NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameVISE GRIPS
Generic NameCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
Product CodeGDJ
Date Received2018-09-05
Returned To Mfg2018-08-22
Model NumberNA
Catalog Number07.02104.001
Lot Number63355623
OperatorHEALTH PROFESSIONAL
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 2018-09-05

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