MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM; PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

Reference: (b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to orthopediatrics for investigation.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 posterior spinal fusion, the patient underwent a revision procedure due to a fractured pedicle screw.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed as lot number of device involved in the incident is unknown.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.

• Brand Name: RESPONSE 5.5/6.0 UNIAXIAL PEDICLE SCREW 6.0MM X 40MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw IN 46582
• MDR Report Key: 8237875
• MDR Text Key: 132785790
• Report Number: 3006460162-2019-00002
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-1300-0640
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention