PEDICLE PROBE - STRAIGHT LUMBAR 07.02067.001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-09-12 for PEDICLE PROBE - STRAIGHT LUMBAR 07.02067.001 manufactured by Zimmer Biomet Spine Inc..

Event Text Entries

[159608776] Without a product return, no product evaluation is able to be conducted. The lot number is unknown; therefore the device history records are unable to be reviewed. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10


[159608777] It was reported that during a surgical procedure, the tip of the pedicle probe fractured off. The tip was retrieved with additional bone removal and the case was completed using a larger diameter screw and dbm paste. There was surgical delay longer than 30 minutes associated with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012447612-2019-00385
MDR Report Key9008723
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-09-12
Date of Report2019-09-12
Date of Event2019-08-13
Date Mfgr Received2019-08-16
Date Added to Maude2019-09-12
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 NamePEDICLE PROBE - STRAIGHT LUMBAR
Generic NamePROBE
Product CodeHXB
Date Received2019-09-12
Model NumberNA
Catalog Number07.02067.001
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET SPINE INC.
Manufacturer Address10225 WESTMOOR DR. NA WESTMINSTER CO 80021 US 80021


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-09-12

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