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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS CORP. SCREW; SCREW FIXATION BONE
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ORTHOPEDIATRICS CORP. SCREW; SCREW FIXATION BONE Back to Search Results
Model Number 00-903-2520
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 Name
SCREW
Type of Device
SCREW FIXATION BONE
Manufacturer (Section D)
ORTHOPEDIATRICS CORP.
warsaw IN 46582
MDR Report Key7645664
MDR Text Key112762190
Report NumberMW5078123
Device Sequence Number2
Product Code HWC
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 No Information
Device Model Number00-903-2520
Device Catalogue Number00-903-2520
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age10 YR
Patient Weight26
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