MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC 5.5/6.0 RESPONSE POLYAXIAL PEDICLE SCREW 7.0MM X 70MM; PEDICLE SCREW SPINAL SYSTEM

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Reference: (b)(4).Customer has indicated that the product will not be returned to ortho-pediatrics 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 report that following the implantation of a response spine system, two polyaxial screws fractured.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: 5.5/6.0 RESPONSE POLYAXIAL PEDICLE SCREW 7.0MM X 70MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw IN 46582
• Manufacturer Contact: leigh jessop ; 2850 frontier drive; warsaw, IN 46582 ; 5742670872
• MDR Report Key: 8392476
• MDR Text Key: 139825883
• Report Number: 3006460162-2019-00007
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-1300-2770
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2019
• 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