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 Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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: 9862384
• Report Number: 3006460162-2020-00047
• Device Sequence Number: 3307773
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2020

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: 02/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1