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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 100° X 4.5 MM VARUS PLATE 6 MM OFFSET, 4 HOLE

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ORTHOPEDIATRICS, CORP 100° X 4.5 MM VARUS PLATE 6 MM OFFSET, 4 HOLE Back to Search Results
Model Number 00-0907-1324
Device Problem Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Date 11/16/2021
Event Type  malfunction  
Event Description
Surgery to remove the plaque. During this surgery they saw that the screw had been joined to the plate by means of a "cold weld" and it was very complete to remove the screw. Delay greater than 30 minutes.
 
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Brand Name100° X 4.5 MM VARUS PLATE 6 MM OFFSET, 4 HOLE
Type of DeviceVARUS 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 Key13714886
MDR Text Key289495873
Report Number3006460162-2021-00057
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number00-0907-1324
Device Catalogue Number00-0907-1324
Device Lot Number641079-L032382
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No

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