MAUDE Adverse Event Report: ORTHOPEDIATRICS, CORP RESPONSE SPINE 5.5/6.0 UNIAXIAL PEDICLE SCREW 6MM X 40MM; PEDICLE SCREW SPINAL SYSTEM

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to orthopediatrics for investigation as it is still implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that following a spinal deformity correction procedure, an x-ray taken at the one year follow-up revealed a possible fractured pedicle screw.The screw is located at the left pedicle at the t12 vertebrae.The patient presented with back pain following a collision in physical education class.Based on the computerized tomography scans and patient pain levels, a revision procedure could be performed at a later date.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: RESPONSE SPINE 5.5/6.0 UNIAXIAL PEDICLE SCREW 6MM X 40MM
• 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: leigh jessop ; 2850 frontier drive; warsaw, IN 46582 ; 5742670872
• MDR Report Key: 7183941
• MDR Text Key: 97053248
• Report Number: 3006460162-2018-00002
• Device Sequence Number: 1
• Product Code: OSH
• UDI-Device Identifier: 00084113210032
• UDI-Public: 0084113210032
• 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
• Type of Report: Initial
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00-1300-0640
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2017
• 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
• Patient Weight: 71