MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP 90 DEGREE LOCKING CANNULATED INFANT BLADE PLATE, 35MM, 5MM, 3-HOLE; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference: (b)(4).The following is being submitted to relay additional information.Updated patient is being treated for spasticity with a baclophen pump.Patient is non-ambulatory.Device manufacture date: updated 03may2018.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 no further action is required as no trends were identified.Root cause was unable to be determined.
Event or Problem Description
It has been reported that approximately four weeks following the placement of a locking cannulated blade plate, the patient underwent a revision due to plate fracture.No additional patient consequences were reported.

• Brand Name: 90 DEGREE LOCKING CANNULATED INFANT BLADE PLATE, 35MM, 5MM, 3-HOLE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• MDR Report Key: 9720942
• Report Number: 3006460162-2019-00092
• Device Sequence Number: 19433221
• Product Code: HRS
• UDI-Device Identifier: 00841132109717
• UDI-Public: (01)00841132109717(10)M91805-B
• 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): 01/10/2020

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: 00-1200-1002
• Device Lot Number: M91805-B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2019
• 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: 10 YR
• Patient Weight: 40