MAUDE Adverse Event Report: ORTHOPEDIATRICS CORP. RESPONSE 5.5/6.0 SPINE SYSTEM; PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

Catalog Number 00-1003-4001

Device Problems Detachment Of Device Component (1104); Device Issue (2379)

Patient Problem Congenital Defect/Deformity (1782)

Event Date 03/02/2017

Event Type  Injury  

Event Description

Scheuermann's kyphosis case done (b)(6) 2016.Used all poly screws and 6.0 cobalt chrome rods.Patient came back for 1 year follow up, and bottom 3 screws on both sides became disengaged.At time of revision surgery, sales rep noted that surgeon stated that he had used the wrong instrument (jimmy device) to actually reduce rod into pedicle screws, so therefore they were not tightened as he had thought.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Corrections: patient age, udi, explant date.Additional information: customer did not return the explanted devices to orthopediatrics, corp.Correction/removal number: 3006460162-04-11-2017-001-c.A device history records review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to the surgeon not adequately following the steps outlined in the surgical technique for "final tightening" of the set screw and the confirmation that the rod is fully seated into the bottom of the pedicle screw prior to tinal tightening.Updated surgical technique, sales rep notifications and training has been updated and/or distributed.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: RESPONSE 5.5/6.0 SPINE SYSTEM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
• Manufacturer (Section D): ORTHOPEDIATRICS CORP.; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOPEDIATRICS CORP.; 2850 frontier drive; warsaw IN 46582
• Manufacturer Contact: mark fox ; 2850 frontier drive; warsaw, IN 46582 ; 5742686379
• MDR Report Key: 6441955
• MDR Text Key: 71099401
• Report Number: 3006460162-2017-00005
• Device Sequence Number: 1
• Product Code: OSH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K15600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 01/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00-1003-4001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: SEE H10
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR