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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOFIX SRL FITBONE LOCKING SCREW

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ORTHOFIX SRL FITBONE LOCKING SCREW Back to Search Results
Model Number 60000365
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Insufficient Information (4580)
Event Date 11/12/2020
Event Type  malfunction  
Event Description
Information provided states that the patient had a fitbone nail implanted in femur on (b)(6) 2020. It was noticed at a post-op follow up that the screw had backed out. The patient underwent a revision surgery on (b)(6) 2020 to replace the screw. Patient is currently doing well.
 
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Brand NameFITBONE
Type of DeviceLOCKING SCREW
Manufacturer (Section D)
ORTHOFIX SRL
via delle nazioni 9
bussolengo, verona 37012
IT 37012
MDR Report Key11012690
MDR Text Key242902634
Report Number2183449-2020-00009
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 11/13/2020,12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60000365
Device Catalogue Number60000365
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date11/13/2020
Event Location No Information
Date Report to Manufacturer11/13/2020
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/15/2020 Patient Sequence Number: 1
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