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
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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: 13895294
• Product Code: HRS
• UDI-Device Identifier: 00841132109717
• UDI-Public: (01)00841132109717(10)M78448-B
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K110959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

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: Physician
• 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
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 09/11/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 11 YR
• Patient Weight: 25