MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC RESPONSE 5.5/6.0 ROD REDUCER ASSEMBLY; 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3006460162-2020-00041.Product has been received by orthopediatrics and the investigation is in process.
Event or Problem Description
It has been reported that during the inspection of a rod reducer, it was found to be fractured.The location of the fragmented component is unknown.No adverse events have been reported as a result of the malfunction.

• Brand Name: RESPONSE 5.5/6.0 ROD REDUCER ASSEMBLY
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw, in
• MDR Report Key: 9788358
• Report Number: 3006460162-2020-00042
• Device Sequence Number: 13919687
• 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): 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1