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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD. STABILIT VERTEBROPLASTY KIT

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MERIT MEDICAL IRELAND LTD. STABILIT VERTEBROPLASTY KIT Back to Search Results
Catalog Number 2003/A
Device Problem Fracture (1260)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 05/23/2017
Event Type  Injury  
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 reported that during bone preparation with the osteotome and while trying to pull back the instrument the flexible tip of the instrument broke inside the vertebral body.An additional procedure was performed to remove the piece.The procedure was finished with cement augmentation delivered monopedicular.
 
Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were found.
 
Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed.The root cause was determined to be use of the device where contraindicated.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were found.
 
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Brand Name
STABILIT VERTEBROPLASTY KIT
Type of Device
VERTEBROPLASTY KIT
Manufacturer (Section D)
MERIT MEDICAL IRELAND LTD.
parkmore industrial estate
galway,
EI 
Manufacturer (Section G)
MERIT MEDICAL IRELAND LTD.
parkmore industrial estate
galway,
EI  
Manufacturer Contact
casey hughes, ms, cqe, csqp
1600 west merit parkway
south jordan, UT 84095
MDR Report Key6646421
MDR Text Key77727050
Report Number9616662-2017-00020
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K072496
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 05/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2018
Device Catalogue Number2003/A
Device Lot NumberK1091575
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/24/2017
Initial Date FDA Received06/16/2017
Supplement Dates Manufacturer ReceivedNot provided
09/11/2017
Supplement Dates FDA Received06/22/2017
09/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
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