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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC PEDINAIL 4.5MM X 38MM CORTICAL SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ORTHOPEDIATRICS, INC PEDINAIL 4.5MM X 38MM CORTICAL SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Non-union Bone Fracture (2369)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Customer has indicated that the product is still implanted and will be returned if/when it is removed. Multiple medwatches were filed for this event. Please see associated reports: 3006460162-2018-00077 and 3006460162-2018-00078. Concomitant medical products: item: 10-1500-3042, 4. 5mm x 42mm cortical screw, lot: unknown. Item: 10-1500-3060, 4. 5mm x 60mm cortical screw, lot: unknown.
 
Event Description
It has been reported that following a rotational osteotomy on her right leg, the patient presented with three fractured distal screws. There was very little evidence of callus at the osteotomy site. The patient is currently undergoing shockwave therapy to encourage healing. No additional patient consequences were reported.
 
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Brand NamePEDINAIL 4.5MM X 38MM CORTICAL SCREW
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
ORTHOPEDIATRICS, INC
2850 frontier drive
warsaw IN 46582
Manufacturer (Section G)
ORTHOPEDIATRICS, INC
2850 frontier drive
warsaw IN 46582
Manufacturer Contact
leigh jessop
2850 frontier drive
warsaw, IN 46582
5742670872
MDR Report Key8181917
MDR Text Key131339059
Report Number3006460162-2018-00076
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K083726
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial
Report Date 12/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number10-1500-3038
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/19/2018 Patient Sequence Number: 1
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