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

Catalog Number 00-1300-6051

Device Problem Malposition of Device (2616)

Patient Problem Congenital Defect/Deformity (1782)

Event Date 08/17/2016

Event Type  Injury  

Event Description

Use error by surgeon.Spine rod cut too short for final construct.Most distal screw did not have adequate purchase on spine rod as seen in x-ray.Discovered rod/screw disassociation on follow up visit.

• 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: 5945569
• MDR Text Key: 54526614
• Report Number: 3006460162-2016-00004
• Device Sequence Number: 1
• Product Code: OSH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130655
• 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: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00-1300-6051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2016
• 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: 16 YR