MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC ORTHOPEDIATRICS RESPONSE SPINE LARGE SET SCREW

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant devices: item: 00-1003-4001, response large set screw, lot: unknown, quantity: 19; item: 00-1003-6001, response 5.5mm rod, 500mm, lot: unknown, quantity: 2; item: 00-1300-2630, response 5.5/6.0 polyaxial pedicle screw 6.0mm x 30mm, lot: unknown, quantity: 9; item: 00-1300-2635, response 5.5/6.0 polyaxial pedicle screw 6.0mm x 35mm, lot: unknown, quantity: 3; item: 00-1300-2740, response 5.5/6.0 polyaxial pedicle screw 7.0mm x 40mm, lot: unknown, quantity: 2; item: 00-1300-3041, response adjustable cross connector small, lot: unknown; item: 00-1300-5034, response 5.5/6.0 fixed cross connector, 34mm, lot: unknown; item: 00-1300-3735, response 5.5/6.0 polyaxial reduction pedicle screw 7, lot: unknown quantity: 2; item: 00-1300-3860, response 5.5/6.0 polyaxial reduction pedicle screw 8, lot: unknown; item: 00-1300-3870, response 5.5/6.0 polyaxial reduction pedicle screw 8, lot: unknown; item: 01-1300-3000, 1.25mm rounded guide wire 100mm length, lot: unknown, quantity: 2.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that following the placement of the response spine system, the patient underwent a revision procedure.During the revision it was discovered that a large set screw was loose but still engaged.The construct was removed and replaced.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Part shows wear as a result of being loose.No way of determining failure mode based on returned part.Review of the photographs of x-rays shows the patient had a severe curve at the bottom of their spine due to spina bifida.This curve results in there being additional leverage on the moment arm at the bottom portion of the construct.In the email that contained the x-rays there was also a summary from a meeting that was had with the surgeon.In this summary it was noted the options for additional fixation at the bottom of the construct were limited due to the condition.It was also noted the surgeon did not believe this was a hardware problem.Device history records were reviewed and no discrepancies were found.The device was made to specification and there have been no recent design changes to the screw.Based on the photographs of the x-rays and the information provided from the meeting with the surgeon it was determined the cause of the loose set screw was due to the patient's condition.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Orthopediatrics will continue to monitor for trends.

• Brand Name: ORTHOPEDIATRICS RESPONSE SPINE LARGE SET SCREW
• Type of Device: LARGE SET SCREW
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw IN 46582
• MDR Report Key: 7579252
• MDR Text Key: 110463519
• Report Number: 3006460162-2018-00033
• Device Sequence Number: 1
• Product Code: OSH
• Combination Product (y/n): N
• PMA/PMN Number: K160466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00-1003-4001
• Device Lot Number: M-85826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Weight: 32