1.5 LACTOSORB SYSTEM 1.5 X 4 MM LACTOSORB SCREW N/A 915-2315

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 2019-01-09 for 1.5 LACTOSORB SYSTEM 1.5 X 4 MM LACTOSORB SCREW N/A 915-2315 manufactured by Biomet Microfixation.

Event Text Entries

[132519527] (b)(4). Concomitant medical device: biomet microfixation lactosorb system 1. 5 mm adjustable self-drilling tap, catalog #: 915-1595, lot #: ni; therapy date: (b)(6) 2018. Foreign country: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, it was discarded. 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


[132519528] It was reported the surgeon could not insert the first screw during a surgery. Then, the surgeon used this tap and made a pilot hole to other place and attempted to insert the first screw into the new pilot hole but it fractured. Then, the surgeon changed this tap to new one. After that, this new one was used to make a pilot hole and remaining seventeen screws were inserted without any problems. 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 Number0001032347-2019-00020
MDR Report Key8231397
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2019-01-09
Date of Report2019-04-25
Date of Event2018-06-13
Date Mfgr Received2019-03-27
Date Added to Maude2019-01-09
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 Name1.5 LACTOSORB SYSTEM 1.5 X 4 MM LACTOSORB SCREW
Generic NamePOLYMER, EAR, NOSE, AND THROAT, SYNTHETIC, ABSORBABLE
Product CodeNHB
Date Received2019-01-09
Model NumberN/A
Catalog Number915-2315
Lot NumberUNKNOWN
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. Required No Informationntervention 2019-01-09

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