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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS 5.5-6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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ORTHOPEDIATRICS 5.5-6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 00-1300-0740
Device Problem Product Quality Problem (1506)
Patient Problem No Patient Involvement (2645)
Event Date 08/01/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Product has been received by orthopediatrics and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Recall number: 3006460162-08-03-2017-002-r.
 
Event Description
It has been reported by the sales representative that during review of incoming inventory, the screw was discovered to be anodized the incorrect color. No patient involvement. No adverse events have been reported because of the malfunction.
 
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Brand Name5.5-6.0 UNIAXIAL PEDICLE SCREW 7.0MM X 40MM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
ORTHOPEDIATRICS
2850 frontier drive
warsaw IN 46582
Manufacturer (Section G)
ORTHOPEDIATRICS
2850 frontier drive
warsaw IN 46582
Manufacturer Contact
leigh jessop
2850 frontier drive
warsaw, IN 46582
5742670872
MDR Report Key6832046
MDR Text Key84082959
Report Number3006460162-2017-00009
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00841132100462
UDI-Public(01)00841132100462(10)M82791-I
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Remedial Action Recall
Type of Report Initial
Report Date 08/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Medical Equipment Company Technician/Representative
Device Model Number00-1300-0740
Device Catalogue Number00-1300-0740
Device Lot NumberM82791-I
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/01/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberSEE H10

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