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

Catalog Number 00-1003-4355

Device Problem Fracture (1260)

Patient Problem Congenital Defect/Deformity (1782)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

Initial report filed prior to scheduled revision surgery.Return of fractured screws for evaluation has been requested.If devices are returned, they will be evaluated and a follow up report submitted.

Event Description

The proximal portion of both pedicle screws broke off.The screws were located at the bottom of the construct at l3 as part of a t5-l3 fusion.Original date of surgery was (b)(6) 2014.

• Brand Name: RESPONSE 5.5 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: 6229482
• MDR Text Key: 64067442
• Report Number: 3006460162-2016-04355
• Device Sequence Number: 1
• Product Code: OSH
• UDI-Device Identifier: 00084113212119
• UDI-Public: 0084113212119
• 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: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 00-1003-4355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2016
• 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
• Patient Weight: 55