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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARBOFIX ORTHOPEDICS, LTD. CARBOCLEAR X THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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CARBOFIX ORTHOPEDICS, LTD. CARBOCLEAR X THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2021
Event Type  malfunction  
Event Description
Carbofix manufacturers in (b)(4) and sells product in the us. Their new carbon fiber tulip broke off from the screw. Screw needed to be removed with quite a bit of difficulty. Fda safety report id # (b)(4).
 
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Brand NameCARBOCLEAR X
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
CARBOFIX ORTHOPEDICS, LTD.
MDR Report Key13976897
MDR Text Key288495776
Report NumberMW5108703
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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