LACTOSORB SYSTEM 14MM RAPID FLAP N/A 915-0020

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-24 for LACTOSORB SYSTEM 14MM RAPID FLAP N/A 915-0020 manufactured by Biomet Microfixation.

Event Text Entries

[188258617] (b)(4). 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. Concomitant medical products: baxter fibrin sealant patch, part# ni, lot# ni; johnson and johnson evical fibrin sealant, part# ni, lot# ni; unknown pds sutures, part# ni, lot# ni. The user facility is foreign; therefore, a facility medwatch report will not be available. Report source:? (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[188258618] It was reported the bio-absorbable cranial fixation clamps fractured intra-operatively during a infratentorial craniotomy. Another pack of bone clamps was opened but were found in an unusable condition. The fascia sutures, fibrin patch and fibrin sealant that were already in place were removed to facilitate removal of the fractured cranial fixation clamps, resulting in a 20 minute delay. The patient was closed with pds sutures. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001032347-2020-00185
MDR Report Key9872164
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-03-11
Date Mfgr Received2020-03-19
Device Manufacturer Date2018-05-22
Date Added to Maude2020-03-24
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 NameLACTOSORB SYSTEM 14MM RAPID FLAP
Generic NamePLATE, BONE
Product CodeJEY
Date Received2020-03-24
Model NumberN/A
Catalog Number915-0020
Lot Number615760
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 2020-03-24

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