MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC 90 DEGREE CANNULATED ADOLESCENT BLADE PLATE 55MM X 6MM OFFSET, 6.5MM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/04/2020
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 following the placement of a locking cannulated blade plate, the patient presented with pain.The plate was found to be fractured and the patient underwent a revision procedure the following day.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d10 yes; h3 yes; h6 patient code: 1994; h6 device code: 1260; h6 method code: 3331 -10 - 4110; h6 result code: 3252; h6 conclusion code: 4315; complaint sample was evaluated and the reported event was confirmed.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined.

• Brand Name: 90 DEGREE CANNULATED ADOLESCENT BLADE PLATE 55MM X 6MM OFFSET, 6.5MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• MDR Report Key: 9993786
• Report Number: 3006460162-2020-00056
• Device Sequence Number: 4597660
• Product Code: HRS
• UDI-Device Identifier: 00841132110171
• UDI-Public: (01)00841132110171(10)177626-C
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: 00-1200-4503
• Device Lot Number: 177626-C
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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
• Patient Age: 16 YR
• Patient Weight: 69