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 2018-06-13 for 1.5 X 4 MM LACTOSORB SCREW N/A 915-2315 manufactured by Biomet Microfixation.

Event Text Entries

[111348292] (b)(4). Concomitant medical product: biomet microfixation 1. 5 mm self-drilling lactosorb tap, dense bone catalog #: 915-1590-01 lot #: ni, biomet microfixation battery powered power driver catalog #: 50-1000 lot #: ni, biomet microfixation 1. 5 mm system power driver battery catalog #: 50-1010 lot #: 723700. Concomitant medical products therapy date: (b)(6) 2018. (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00360.
Patient Sequence No: 1, Text Type: N, H10


[111348293] It was reported the surgeon used the dense bone tap, inserted six screws, and then finished using the heat pen. However, all six screws have come off the bone. The customer believes the incident was caused by the bone tap. There was a twenty minute delay. The patient did not retain a foreign body and the surgery was completed using another device. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001032347-2018-00359
MDR Report Key7598048
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2018-06-13
Date of Report2018-11-15
Date of Event2018-03-29
Date Mfgr Received2018-10-16
Device Manufacturer Date2017-10-16
Date Added to Maude2018-06-13
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 X 4 MM LACTOSORB SCREW
Generic NameBONE SCREW
Product CodeNHB
Date Received2018-06-13
Model NumberN/A
Catalog Number915-2315
Lot Number481170
ID Number(01) 0 0841036 05518 9
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
10 2018-06-13

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