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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS CORP. ORTHOPEDIATRIC FEMORAL BLADE PLATE PLATE, FIXATION, BONE

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ORTHOPEDIATRICS CORP. ORTHOPEDIATRIC FEMORAL BLADE PLATE PLATE, FIXATION, BONE Back to Search Results
Model Number 00-1200-3503
Device Problems Difficult to Remove (1528); Metal Shedding Debris (1804); Device Damaged by Another Device (2915)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/19/2018
Event Type  malfunction  
Event Description
Patient came to the operating room to have femoral blade plate and three screws removed. Proximal and distal screws were removed without difficulty. The middle screw per surgeon was cold-welded into the plate. He attempted to remove the screw with two different screw drivers, but damaged the drivers while attempting this. He then used the broken screw removal set but was also unsuccessful. He then used a burr to remove the head of the screw and was then able to remove the plate. He then used a trephine to remove the rest of the screws. The wound was irrigated with saline to remove the metal shavings. Per the surgeon this added 30 minutes to the patient's anesthesia/case time.
 
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Brand NameORTHOPEDIATRIC FEMORAL BLADE PLATE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
ORTHOPEDIATRICS CORP.
warsaw IN 46582
MDR Report Key7645664
MDR Text Key112762190
Report NumberMW5078123
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/26/2018
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received06/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number00-1200-3503
Device Catalogue Number00-1200-3503
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/27/2018 Patient Sequence Number: 1
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