TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL N/A 24-6562

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-15 for TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL N/A 24-6562 manufactured by Biomet Microfixation.

Event Text Entries

[175188725] Zimmer biomet complaint (b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. It is unknown at this time if the device will be returned for evaluation; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00068, 0001032347-2020-00069, 0001032347-2020-00071, 0001032347-2020-00072, 0001032347-2020-00073, 0001032347-2020-00074. Medical products: tmj system right standard mandibular component, part# 24-6555, lot# 842720b, tmj system left standard mandibular component, part# 24-6556, lot# 793820b, tmj system right fossa component, small, part# 24-6562, lot# 861210a, tmj system left fossa component, small, part# 24-6563, lot# 864820a, 2. 4mm system high torque (ht) cross-drive screw, part# 91-2710, lot# unk, tmj system cross drive fossa screw, part# 99-6577, lot# unk, tmj system cross drive fossa screw, part# 99-6579, lot# unk.
Patient Sequence No: 1, Text Type: N, H10


[175188726] It was reported the patient underwent a bilateral revision of temporomandibular joint prostheses due to an unknown reason. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001032347-2020-00070
MDR Report Key9592344
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-01-15
Date of Report2020-01-15
Date Mfgr Received2019-12-20
Device Manufacturer Date2018-10-30
Date Added to Maude2020-01-15
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 NameTMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL
Generic NameJOINT, TEMPOROMANDIBULAR, IMPLANT
Product CodeLZD
Date Received2020-01-15
Model NumberN/A
Catalog Number24-6562
Lot Number861210A
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. Hospitalization; 2. Required No Informationntervention 2020-01-15

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