MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP ORTHOPEDIATRICS 90 DEGREE INFANT LCB 35MM X 5MM X 3-HOLE ORTHOPEDIATRICS LOCKING CANNULATED BLADE PLATE

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). Foreign source - (b)(6). Customer has indicated that the product is in process of being returned to orthopediatrics for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that following the close of a derotational osteotomy procedure, the infant locking cannulated blade plate was found, via x-ray, to be bent. The patient was re-opened and the infant blade plate replaced with a child blade plate. No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Photographs of x-rays confirmed that the plate was bent. The device was not returned for evaluation. The device was made to specification and there were no manufacturing deviations. There have been no recent design changes. A root cause was unable to be determined. Per the system instructions for use, a risk associated with the use of this device is "bending, fracture, or migration of the implant". If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Orthopediatrics will continue to monitor for trends.

• Brand Name: ORTHOPEDIATRICS 90 DEGREE INFANT LCB 35MM X 5MM X 3-HOLE
• Type of Device: ORTHOPEDIATRICS LOCKING CANNULATED BLADE PLATE
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw IN 46582
• MDR Report Key: 7366633
• Report Number: 3006460162-2018-00016
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841132109717
• UDI-Public: (01)00841132109717(10)M78448-B
• Combination Product (y/n): N
• PMA/PMN Number: K110959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 00-1200-1002
• Device Lot Number: M78448-B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Weight: 25
• Patient Outcome(s): Hospitalization; Required Intervention