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

Model Number 00-1300-4001

Device Problem Device Issue (2379)

Patient Problem Congenital Defect/Deformity (1782)

Event Type  Injury  

Event Description

Surgeon advised that he had a patient come in for routine follow up and presented with pain.X-ray indicated that both of the lateral connectors have disengaged from the iliac screws at some point between the office visit and the surgery ((b)(6) 2016).Revision surgery performed on (b)(6) 2017: lateral connectors dissociated from the 2 screws at the bottom of the construct.One side was 5.5 cocr, the other side was a 6.0 cocr rod the initial surgery predated surgeon retraining and his use of towers at the bottom of the construct.Removed 2 screws that were spanning the si joint.Removed all set screws and rods from the construct.Left the pedicle screws in place.Added 2 7 x 25 poly screws in s1 and 28 x 80 poly screws in s2 replaced the original rods with 5.5 titanium rods.Utilized towers at bottom of the construct and most other pedicle screws.Jiminys used to help reduce the rod and towers for final reduction.Used 95inlb torque drivers to set the screws.Utilized a fixed t-handle to provide additional torque to the set screws.

• 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: 6406440
• MDR Text Key: 70013992
• Report Number: 3006460162-2017-00314
• Device Sequence Number: 1
• Product Code: OSH
• Combination Product (y/n): N
• PMA/PMN Number: K150600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00-1300-4001
• Was Device Available for Evaluation?: No
• Device Age: 6 MO
• Date Manufacturer Received: 02/14/2017
• 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): Required Intervention
• Patient Age: 14 YR