"2.4MM" LOCKING RECON SYSTEM RIGHT ADD-ON CONDYLE 1 CONDYLE 3 SCREWS N/A 01-2692

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-08-07 for "2.4MM" LOCKING RECON SYSTEM RIGHT ADD-ON CONDYLE 1 CONDYLE 3 SCREWS N/A 01-2692 manufactured by Biomet Microfixation.

Event Text Entries

[116299872] (b)(4). Medical product: biomet microfixation total mandibular system add-on condyle plate, catalog #: 24-4545, lot #: ni, unknown screws, catalog #: ni, lot #: ni. Therapy date: unknown. Report source: foreign country - (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00465.
Patient Sequence No: 1, Text Type: N, H10


[116299873] It was reported a revision was performed due to a plate fracture. No additional patient consequences were reported. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001032347-2018-00464
MDR Report Key7758945
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2018-08-07
Date of Report2018-12-20
Date of Event2018-06-18
Date Mfgr Received2018-12-07
Date Added to Maude2018-08-07
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. MICHELLE COLE
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
Event Type3
Type of Report3

Device Details

Brand Name"2.4MM" LOCKING RECON SYSTEM RIGHT ADD-ON CONDYLE 1 CONDYLE 3 SCREWS
Generic NameADD-ON CONDYLE
Product CodeNEI
Date Received2018-08-07
Model NumberN/A
Catalog Number01-2692
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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. Hospitalization; 2. Required No Informationntervention 2018-08-07

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