MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP RAIL, MONO 200MM

Catalog Number	800-200
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Date of initial surgery: (b)(6) 2024.Details: right ulna acute correction, excision of osteochondroma, and application of rail fixator.Surgeon: (b)(6).Complication: loosening of proximal clamp of rail causing loss of correction 6 weeks into lengthening process.This was picked up on x-ray one week prior to the revision surgery and the patient had noticed the clamp had shifted and was no longer perpendicular to the half pins.When we revised the rail fixator intra-op we noted that all of the locking mechanisms on the proximal clamp were loose so suspect failure of this clamp altogether.

• Brand Name: RAIL, MONO 200MM
• Common Device Name: RAIL, MONO 200MM
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer (Section G): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN
• Manufacturer Contact: james gunnels ; 2850 frontier drive; warsaw, IN
• MDR Report Key: 20458153
• Report Number: 3006460162-2024-00056
• Device Sequence Number: 7794232
• Product Code: KTT
• UDI-Device Identifier: 00841132142837
• UDI-Public: 00841132142837
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 800-200
• Device Lot Number: VA11656
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Weight: 54 KG