1.5MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW N/A 91-1509

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-14 for 1.5MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW N/A 91-1509 manufactured by Biomet Microfixation.

Event Text Entries

[179452363] (b)(4). The device will not be returned for analysis as it was discarded by the hospital; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[179452364] It was reported that a screw fractured upon insertion into the anterior ramus of the patient's mandible. The surgeon trephined around the retained screw body to facilitate removal of the screw fragment. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001032347-2020-00110
MDR Report Key9711285
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-02-14
Date of Report2020-02-14
Date of Event2020-01-08
Date Mfgr Received2020-01-16
Date Added to Maude2020-02-14
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 ContactMRS. JENNIFER DELANEY
Manufacturer Street1520 TRADEPORT DRIVE
Manufacturer CityJACKSONVILLE FL 32218
Manufacturer CountryUS
Manufacturer Postal32218
Manufacturer Phone9047414400
Manufacturer G1BIOMET MICROFIXATION
Manufacturer Street1520 TRADEPORT DRIVE
Manufacturer CityJACKSONVILLE FL 32218
Manufacturer CountryUS
Manufacturer Postal Code32218
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand Name1.5MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW
Generic NamePLATE, BONE
Product CodeJEY
Date Received2020-02-14
Model NumberN/A
Catalog Number91-1509
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMET MICROFIXATION
Manufacturer Address1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-14

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