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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER INC. TORNIER AEQUALIS HUMERAL NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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TORNIER INC. TORNIER AEQUALIS HUMERAL NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 0020600
Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)
Patient Problem Failure of Implant (1924)
Event Date 01/28/2021
Event Type  Injury  
Event Description
Patient had a proximal humerus fracture on (b)(6) 2020 that was fixed on (b)(6) 2020 using a tornier aequalis humeral nail 8x130mm and 3 proximal 5. 0 interlocking screws and 2 distal 4. 3mm interlocking screws. The nail had cut out laterally resulting in a revision surgery removing the nail and inserting a fibular strut graft and a locking proximal humerus plate on (b)(6) 2021. Fda safety report id # (b)(4).
 
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Brand NameTORNIER AEQUALIS HUMERAL NAIL
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
TORNIER INC.
MDR Report Key11273039
MDR Text Key230538246
Report NumberMW5099185
Device Sequence Number1
Product Code HSB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 01/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0020600
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/02/2021 Patient Sequence Number: 1
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