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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL, INC. CROSSTEX TYVEK INTRAARTICULAR DEVICE WRAP STERIZATION

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CROSSTEX INTERNATIONAL, INC. CROSSTEX TYVEK INTRAARTICULAR DEVICE WRAP STERIZATION Back to Search Results
Model Number TSP-185
Device Problem Crack (1135)
Patient Problem No Code Available (3191)
Event Date 01/23/2020
Event Type  malfunction  
Event Description
Pt was undergoing a left total knee replacement and while placing the intraarticular device it cracked into several pieces. The wound was inspected and irrigated and area was x-rayed. X-ray was negative and procedure continued without further issues. Zimmer biomet, (b)(4). Fda safety report id# (b)(4).
 
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Brand NameCROSSTEX TYVEK INTRAARTICULAR DEVICE
Type of DeviceWRAP STERIZATION
Manufacturer (Section D)
CROSSTEX INTERNATIONAL, INC.
MDR Report Key9653637
MDR Text Key177584819
Report NumberMW5092658
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTSP-185
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/30/2020 Patient Sequence Number: 1
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