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

Catalog Number 00-1003-6001

Device Problem Material Separation (1562)

Patient Problem Congenital Defect/Deformity (1782)

Event Type  Injury  

Manufacturer Narrative

Surgeon stated he was certain that the dissociation occurred due to the rod not being fully seated, and the driver not being able to overcome the force of the 6.0mm cocr rod.Surgeon further stated that when he performed the revision surgery on the patient, he observed that the rod was not fully seated.Upon utilizing the reduction tower to fully seat the rod into the pedicle screw, he observed that the rod did reduce further.He then final tightened the set screw using the torque limiting driver handle.

Event Description

Set screw disassociated from polyaxial screw causing rod to disengage from polyaxial screw.Surgeon discovered at 6-week follow-up visit with patient.

• Brand Name: RESPONSE 5.5/6.0 SPINE SYSTEM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• 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: 5930748
• MDR Text Key: 53995751
• Report Number: 3006460162-2016-00002
• Device Sequence Number: 1
• Product Code: OSH
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00-1003-6001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention