MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC ORTHOPEDIATRICS ADOLLOCKING CANNULATED BLADE PLATE, 65MM, 14MM, 4-HOLE; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	07/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference: (b)(4).Complaint sample was not returned for evaluation.Reported event was confirmed through images provided by the customer.Dhr was reviewed.No deviations or rework was reported.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was determined to be patient non-compliance.The patient was intended to be non-weight bearing post-op but admitted to walking long distances.
Event or Problem Description
It was reported that six weeks following the placement of a locking cannulated blade plate, the patient heard a "pop" while rolling over in bed.Patient was also walking and running while on non-weight bearing orders.The patient underwent a revision procedure due to fracture of the plate.No additional patient consequences were reported.

• Brand Name: ORTHOPEDIATRICS ADOLLOCKING CANNULATED BLADE PLATE, 65MM, 14MM, 4-HOLE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• MDR Report Key: 9721840
• Report Number: 3006460162-2019-00047
• Device Sequence Number: 2401044
• Product Code: HRS
• UDI-Device Identifier: 00841132110263
• UDI-Public: (01)00841132110263(10)176086-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
• Report Date (Section B): 02/18/2020

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: 00-1200-4519
• Device Lot Number: 176086-C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2019
• Initial Report FDA Received Date: 02/18/2020
• 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: Required Intervention
• Patient Age: 13 YR