HTR-PMI KOVALIOVAS LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT N/A PM619800

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 2017-12-12 for HTR-PMI KOVALIOVAS LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT N/A PM619800 manufactured by Biomet Microfixation.

Event Text Entries

[94483093] Zimmer biomet complaint (b)(4). (b)(4). Concomitant medical products - zimmer biomet htr-pmi catalog #: pm619804 lot #: 776380. Therapy date - (b)(6) 2017. Foreign country - (b)(6). The device will not be returned for analysis; 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 report: 0001032347-2017-00864.
Patient Sequence No: 1, Text Type: N, H10


[94483094] It was reported during implantation of bilateral htr implants, it was noticed that the implants did not fit without over-compressing the brain. It is still unclear whether it is due to the swelling of the brain or the implants design being too flat. The presumption of the surgeon is the implants are too shallow. Different methods were used to attempt to get the implants to fit, this resulted in a surgical delay of approximately 45 minutes. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001032347-2017-00863
MDR Report Key7107591
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2017-12-12
Date of Report2018-08-06
Date of Event2017-08-29
Date Mfgr Received2018-03-15
Device Manufacturer Date2017-08-17
Date Added to Maude2017-12-12
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 KOVALIOVAS LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT
Generic NameHARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT
Product CodeKKY
Date Received2017-12-12
Model NumberN/A
Catalog NumberPM619800
Lot Number776370
ID NumberSEE NARRATIVE IN H10
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 2017-12-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.