MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC 90 DEGREE CANNULATED ADOL BLADE PLATE, 60MM X 14MM, OFFSET X 4-HOLE; LOCKING CANNULATED BLADE PLATE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to orthopediatrics for investigation.
Event or Problem Description
It has been reported that approximately four months following the placement of a locking cannulated blade plate, the plate was discovered to be fractured.The patient was revised.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: h4 updated 27 apr 2017.H6 updated method 3331, 4109 and 10.H6 updated results 3252.H6 updated conclusion 4315.Complaint sample was returned for evaluation.Reported event was 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 no trends were identified.Root cause was unable to be determined.

• Brand Name: 90 DEGREE CANNULATED ADOL BLADE PLATE, 60MM X 14MM, OFFSET X 4-HOLE
• Common Device Name: LOCKING CANNULATED BLADE PLATE
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• MDR Report Key: 9743842
• Report Number: 3006460162-2019-00052
• Device Sequence Number: 713590
• Product Code: HRS
• UDI-Device Identifier: 00841132110256
• UDI-Public: (01)00841132110256(10)172901-C
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110959
• 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,Followup
• Report Date (Section B): 02/24/2020

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: 00-1200-4518
• Device Lot Number: 172901-C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 51