LEKSELL ANCHOR BOLT LSB-BX-04

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-04-04 for LEKSELL ANCHOR BOLT LSB-BX-04 manufactured by Ad-tech Medical Instrument Corp..

Event Text Entries

[20647014] Multiple anchor bolts were placed in a pediatric patient (actual number unknown). One of the anchor bolts broke while the patient was in an agitated state. The neurosurgeon had to remove the broken piece (threads) surgically. It was reported that patient monitoring was not affected and there was no negative patient outcome.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183456-2013-00002
MDR Report Key3042825
Report Source00
Date Received2013-04-04
Date of Report2013-04-04
Date of Event2013-03-07
Date Mfgr Received2013-03-07
Date Added to Maude2013-06-03
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 FDA0
Event Location0
Manufacturer Street1901 WILLIAM ST.
Manufacturer CityRACINE WI 53404
Manufacturer CountryUS
Manufacturer Postal53404
Manufacturer Phone2626341555
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEKSELL ANCHOR BOLT
Generic NameANCHOR BOLT
Product CodeGYC
Date Received2013-04-04
Model NumberLSB-BX-04
Catalog NumberLSB-BX-04
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAD-TECH MEDICAL INSTRUMENT CORP.
Manufacturer AddressRACINE WI 53404 US 53404


Patients

Patient NumberTreatmentOutcomeDate
10 2013-04-04

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