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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD STABILIT FRACTURE KIT
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MERIT MEDICAL IRELAND LTD STABILIT FRACTURE KIT Back to Search Results
Model Number 00884450379851
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/03/2020
Event Type  malfunction  
Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges during a vertebral augmentation procedure, the tip of the augmentation system detached within the patients vertebral body and was not removed.The detached tip was cemented in place and the procedure completed without any additional consequences to the patient.
 
Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
 
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Brand Name
STABILIT FRACTURE KIT
Type of Device
FRACTURE KIT
Manufacturer (Section D)
MERIT MEDICAL IRELAND LTD
parkmore business park west
ballybrit
galway,
EI 
MDR Report Key9945997
MDR Text Key188864383
Report Number9616662-2020-00007
Device Sequence Number1
Product Code NDN
UDI-Device Identifier00884450379851
UDI-Public00884450379851
Combination Product (y/n)N
PMA/PMN Number
K072496
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2021
Device Model Number00884450379851
Device Catalogue Number2003-01/C
Device Lot NumberK1629950
Was Device Available for Evaluation? No
Date Manufacturer Received04/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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