MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC 90 DEG CANNULATED INFANT BLADE PLATE, 35MM X 5MM, 2-HOLE; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).It is currently unknown if the device is to be returned.
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 plate fracture.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
The follow is being submitted to relay additional information.Updated: b4: date of report: 27 feb 2020.H4: 18 may 2016.H6: updated method codes: 3331, 4109 and 4114.H6: updated results codes: 3252.H6: updated conclusion codes: 4315.Complaint sample was not returned for evaluation.Reported event was not confirmed.Investigation of the dhr did not reveal any process deviations or indications of manufacturing variations that would contribute to the observed failure mode.Risk management file review was deemed appropriate.Review of the complaint history determined that no further action is required as there were no trends identified.Root cause was unable to be determined.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d10 device available for evaluation? yes returned to manufacturer.H3 device evaluated by manufacturer? yes.H6 method code(s): 10 - 3331 - 4109.Complaint sample was evaluated and the reported event was confirmed.Product was evaluated and the plate was found to be fractured.No root cause could be determined.Reference (b)(4).

• Brand Name: 90 DEG CANNULATED INFANT BLADE PLATE, 35MM X 5MM, 2-HOLE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• MDR Report Key: 9729923
• Report Number: 3006460162-2019-00061
• Device Sequence Number: 16718176
• Product Code: HRS
• UDI-Device Identifier: 00841132109748
• UDI-Public: (01)00841132109748(10)M68295-B
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K083286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2020

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: 00-1200-2002
• Device Lot Number: M68295-B
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 10/09/2019; 10/09/2019
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 02/27/2020; 07/16/2020
• 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: Other; Required Intervention; Disability
• Patient Age: 9 YR
• Patient Weight: 25