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

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.

• Brand Name: PEDINAIL 4.5MM X 38MM CORTICAL SCREW
• Type of Device: ROD, 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 Key: 8181917
• MDR Text Key: 131339059
• Report Number: 3006460162-2018-00076
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K083726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• 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 Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10-1500-3038
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Weight: 75