HTR * PMI WALLRAVEN LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT N/A PM620404

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 2018-04-03 for HTR * PMI WALLRAVEN LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT N/A PM620404 manufactured by Biomet Microfixation.

Event Text Entries

[104194205] (b)(4). (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, the device remains implanted in the patient. 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


[104194206] It was reported the implant did not fit on left side. The cut edges were okay, the curvature of the implant was according to the surgeon was not correct. The implant was cut through and supplemented with bone cement. There was a sixty minute delay to the procedure. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001032347-2018-00170
MDR Report Key7392930
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-04-03
Date of Report2018-09-10
Date of Event2018-03-06
Date Mfgr Received2018-08-15
Device Manufacturer Date2018-01-30
Date Added to Maude2018-04-03
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 WALLRAVEN LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT
Generic NameHARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT
Product CodeKKY
Date Received2018-04-03
Model NumberN/A
Catalog NumberPM620404
Lot Number807890
ID Number(01)00841036244903
OperatorPHYSICIAN
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. Required No Informationntervention 2018-04-03

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