MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP RESPONSE 5.5/6.0 MINI REDUCER; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference: (b)(4).Customer has indicated that the product is in process of being returned to orthopediatrics for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It has been reported that during closure of a posterior spinal fusion procedure, a tab was identified to be missing from a rod reducer.Fluoroscopy identified that the tab remained in the patient.Bone graft was removed and the fractured piece was recovered.Bone graft was replaced and incision closed.A delay greater than thirty minutes was noted.No additional patient consequences were reported.

• Brand Name: RESPONSE 5.5/6.0 MINI REDUCER
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• MDR Report Key: 9717724
• Report Number: 3006460162-2020-00006
• Device Sequence Number: 2353293
• Product Code: KWP
• UDI-Device Identifier: 00841132152027
• UDI-Public: (01)00841132152027(10)RC30716-C
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2020

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: 01-1300-6000
• Device Lot Number: RC30716-C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 02/17/2020
• 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; Disability
• Patient Age: 16 YR
• Patient Weight: 84