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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 3.5 MM 1/3 TUBULAR PLATE, 7 HOLE

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ORTHOPEDIATRICS, CORP 3.5 MM 1/3 TUBULAR PLATE, 7 HOLE Back to Search Results
Model Number 00-1005-3007
Device Problem Break (1069)
Patient Problem Fall (1848)
Event Type  malfunction  
Event Description
Plate broke at screw hole/fracture. Implanted in forearm in march, patient fell on same arm in june and the plate broke in half.
 
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Brand Name3.5 MM 1/3 TUBULAR PLATE, 7 HOLE
Type of DeviceTUBULAR PLATE
Manufacturer (Section D)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw IN 46582
Manufacturer (Section G)
ORTHOPEDIATRICS, CORP
2850 frontier drive
warsaw IN 46582
Manufacturer Contact
james gunnels
2850 frontier drive
warsaw, IN 46582
MDR Report Key12162556
MDR Text Key263413119
Report Number3006460162-2021-00027
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 Manufacturer
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number00-1005-3007
Device Catalogue Number00-1005-3007
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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