MAUDE Adverse Event Report: ORTHOPEDIATRICS RESPONSE 5.5/6.0 SPINE SYSTEM; UNKNOWN RESPONSE COBALT CHROME ROD

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to orthopediatrics for investigation.Correction/removal reporting #: 3006460162-04-11-2017-001-c.A post operative x-ray was provided and the complaint was confirmed.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 final 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.

Event Description

It has been reported that following a spinal correction procedure, it was discovered via x-ray that the rods dissociated from the set screws at the bottom of the system construct.The patient underwent a revision in which the response system was removed and replaced with a different system.No additional patient consequences were reported.

• Brand Name: RESPONSE 5.5/6.0 SPINE SYSTEM
• Type of Device: UNKNOWN RESPONSE COBALT CHROME ROD
• Manufacturer (Section D): ORTHOPEDIATRICS; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOPEDIATRICS; 2850 frontier drive; warsaw IN 46582
• Manufacturer Contact: leigh jessop ; 2850 frontier drive; warsaw, IN 46582 ; 5742670872
• MDR Report Key: 6980493
• MDR Text Key: 90384229
• Report Number: 3006460162-2017-00023
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/26/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 16 YR
• Patient Weight: 53