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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASTURA MEDICAL ASTURA IMPLANTS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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ASTURA MEDICAL ASTURA IMPLANTS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)
Patient Problem Insufficient Information (4580)
Event Date 07/06/2020
Event Type  malfunction  
Event Description
Patient brought back to surgery from previous admission due to locking caps on the construction becoming loose. Type of surgery: spinal fusion. Type of equipment: implants. Elderly male had elective t6-l2 instrumentation revision and exploration of fusion. It was found in surgery that spine caps l1/l2 bilaterally and t10 on left were disconnected. Patient has stage iv metastatic melanoma with metastasis to the spine and is s/p (status post) radiation.
 
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Brand NameASTURA IMPLANTS
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
ASTURA MEDICAL
4949 w royal ln
irving TX 75063
MDR Report Key12091976
MDR Text Key259183920
Report Number12091976
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/18/2021
Event Location Hospital
Date Report to Manufacturer06/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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