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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP ORTHOPEDIATRICS 90 DEGREE INFANT LCB 35MM X 5MM X 3-HOLE ORTHOPEDIATRICS LOCKING CANNULATED BLADE PLATE

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ORTHOPEDIATRICS, CORP ORTHOPEDIATRICS 90 DEGREE INFANT LCB 35MM X 5MM X 3-HOLE ORTHOPEDIATRICS LOCKING CANNULATED BLADE PLATE Back to Search Results
Model Number N/A
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Foreign source - (b)(6). Customer has indicated that the product is in process of being returned to orthopediatrics for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It has been reported that following the close of a derotational osteotomy procedure, the infant locking cannulated blade plate was found, via x-ray, to be bent. The patient was re-opened and the infant blade plate replaced with a child blade plate. No additional patient consequences were reported.
 
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Brand NameORTHOPEDIATRICS 90 DEGREE INFANT LCB 35MM X 5MM X 3-HOLE
Type of DeviceORTHOPEDIATRICS LOCKING CANNULATED BLADE 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
leigh jessop
2850 frontier drive
warsaw, IN 46582
5742670872
MDR Report Key7366633
MDR Text Key103336621
Report Number3006460162-2018-00016
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K110959
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00-1200-1002
Device Lot NumberM78448-B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/23/2018 Patient Sequence Number: 1
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