MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC 130 DEG X 3.5MM LOCKING CANNULATED BLADE PLATE, 4-HOLE; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical device: item number: unknown, unknown locking screw, lot number: unknown.Photo of the x-ray was reviewed and confirmed the reported failure.Devices were not returned for analysis.A dhr review was conducted for 00-0907-2104 and found no manufacturing defects or design errors.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.Multiple mdr reports were filed for this event, please see associated reports: 3006460162-2019-00066.
Event or Problem Description
It has been reported that following the placement of a locking cannulated blade plate, the patient underwent a revision due to a locking screw backing out.No additional patient consequences were reported.

• Brand Name: 130 DEG X 3.5MM LOCKING CANNULATED BLADE PLATE, 4-HOLE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw IN 46582
• MDR Report Key: 9386713
• Report Number: 3006460162-2019-00065
• Device Sequence Number: 480579
• Product Code: HRS
• UDI-Device Identifier: 00841132104361
• UDI-Public: (01)00841132104361(10)M113323-G
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2019

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-0907-2104
• Device Lot Number: M113323-G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 YR
• Patient Weight: 36