HTR * PMI GOBIEN LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT N/A PM620450

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 2018-09-06 for HTR * PMI GOBIEN LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT N/A PM620450 manufactured by Biomet Microfixation.

Event Text Entries

[119488178] (b)(4). Concomitant medical device: biomet microfixation htr-pmi gobien right frontal sphenoid parietal temporal implant, catalog #: pm620463, lot #: 810250; unknown manufacturer screws, catalog #: ni, lot #: ni. Therapy date: unknown. Foreign country: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation due to hospital policy. 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 reports: 0001032347-2018-00603.
Patient Sequence No: 1, Text Type: N, H10


[119488179] It was reported a revision due to an infection was performed. The implants were removed during the revision. The infection occurred after surgery during rehabilitation. Attempts have been made and no further information has been provided. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001032347-2018-00602
MDR Report Key7852909
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-09-06
Date of Report2019-02-22
Date Mfgr Received2019-02-11
Device Manufacturer Date2018-02-09
Date Added to Maude2018-09-06
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 GOBIEN LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT
Generic NameHARD TISSUE REPLACEMENT (HTR) - PATIENT MATCHED IMPLANT
Product CodeKKY
Date Received2018-09-06
Model NumberN/A
Catalog NumberPM620450
Lot Number810230
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 2018-09-06

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