MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP RESPONSE 5.5/6.0 FIXED CROSS CONNECTOR, 14MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	N/A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3006460612-2019-00091.Complaint sample was returned for evaluation.No deformity or other damage was visible.The dhr was reviewed and there were no process deviations that would have contributed to the failure.There were no recent design changes prior to manufacturing.Risk management file review was deemed appropriate.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was determined to be patient factors as the patient required an exceptionally narrow rod spacing.
Event or Problem Description
It has been reported that during the placement of spinal stabilization rods, the surgeon was unable to place the fixed cross connectors.A delay great than thirty minutes was noted.No adverse events have been reported as a result of the malfunction.

• Brand Name: RESPONSE 5.5/6.0 FIXED CROSS CONNECTOR, 14MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): ORTHOPEDIATRICS, CORP; 2850 frontier drive; warsaw, in
• MDR Report Key: 9723330
• Report Number: 3006460162-2019-00090
• Device Sequence Number: 2401048
• Product Code: KWP
• UDI-Device Identifier: 00841132103371
• UDI-Public: (01)00841132103371(10)150341-A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150600
• 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): 01/09/2020

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: 00-1300-5014
• Device Lot Number: 150341-A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2019
• 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
• Patient Age: 12 YR
• Patient Weight: 31