MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP PNP 5.0MM X 90MM PARTIALLY THREADED RECON SCREW; ROD, FIXATION, INTRAMEDULLARY

Model Number N/A

Device Problem Migration (4003)

Patient Problem No Information (3190)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

Reference: (b)(4).Concomitant product: item number: unknown, unknown pnp adolescent, lot number: unknown, item number: 00-1506-5095, pnp 5.0mm x 95mm partially threaded screw, lot number: unknown.Customer has indicated that the product will not be returned to orthopediatrics for investigation as it was retained by the patient's family.The investigation is in process.Multiple mdr reports were filed for this event, please see associated reports: 3006460612-2020-00004.

Event Description

It has been reported that following the placement of an intramedullary nail, the patient underwent a revision procedure due to screw migration.No additional patient consequences were reported.

• Brand Name: PNP 5.0MM X 90MM PARTIALLY THREADED RECON SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• Manufacturer Contact: leigh jessop ; 2850 frontier drive; warsaw, in ; 2670872
• MDR Report Key: 9717720
• MDR Text Key: 185788769
• Report Number: 3006460162-2020-00003
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• 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: 00-1506-5090
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 9 YR
• Patient Weight: 54