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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. ACCESS.STABILIT; VERTEBRAL BODY CEMENT CANNULA
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MERIT MEDICAL SYSTEMS INC. ACCESS.STABILIT; VERTEBRAL BODY CEMENT CANNULA Back to Search Results
Catalog Number 1472/C
Device Problems Material Fragmentation (1261); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/11/2021
Event Type  malfunction  
Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges during a posterior hardware removal procedure the access needle bent and broke off in the bone.The foreign body remained within the patient.No patient harm to report.
 
Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.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
ACCESS.STABILIT
Type of Device
VERTEBRAL BODY CEMENT CANNULA
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan UT 84095
MDR Report Key12046746
MDR Text Key260294561
Report Number1721504-2021-00045
Device Sequence Number1
Product Code MDM
UDI-Device Identifier00884450390467
UDI-Public884450390467
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/11/2023
Device Catalogue Number1472/C
Device Lot NumberH2001251
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2021
Date Manufacturer Received07/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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