HTR-PMI JORDAAN RIGHT MAXILLA ZYGOMA ORBITAL IMPLANT N/A PM618014

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-09-10 for HTR-PMI JORDAAN RIGHT MAXILLA ZYGOMA ORBITAL IMPLANT N/A PM618014 manufactured by Biomet Microfixation.

Event Text Entries

[119783408] (b)(4). (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.
Patient Sequence No: 1, Text Type: N, H10


[119783409] It was reported a "small piece" of the implant was removed as it was "mobile and causing irritation. " attempts have been made and no further information has been provided. Later a revision to remove the rest of the implant due to loosening and infection was performed (see medwatch #0001032347-2018-00611 and 0001032347-2018-00612). No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001032347-2018-00613
MDR Report Key7862121
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2018-09-10
Date of Report2019-02-21
Date Mfgr Received2019-02-15
Device Manufacturer Date2016-11-22
Date Added to Maude2018-09-10
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 NameHTR-PMI JORDAAN RIGHT MAXILLA ZYGOMA ORBITAL IMPLANT
Generic NameHARD TISSUE REPLACEMENT (HTR) - PATIENT MATCHED IMPLANT
Product CodeKKY
Date Received2018-09-10
Model NumberN/A
Catalog NumberPM618014
Lot Number721750
Device Expiration Date2019-11-22
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 2018-09-10

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