MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC RESPONSE UNIAXIAL PEDICLE SCREW; PEDICLE SCREW SPINAL SYSTEM

Model Number N/A

Device Problem Fracture (1260)

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

Event Type  Injury  

Manufacturer Narrative

Reference: (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection confirmed that the screw fractured.Investigation of the dhr did not reveal any process deviations or indications of manufacturing variations that would contribute to the observed failure mode.The screw was made to specification, there had been no recent design changes to the screw shaft, and there are no other complaints related to this part number.The root cause was unable to be determined."loss of fixation or implant breakage attributable to delayed or non-union" is a known adverse effect stated in the device ifu.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Orthopediatrics will continue to monitor for trends.

Event Description

It was reported that following the placement of a response spine construct, a screw was found to be fractured at a one-year follow-up.The surgeon believes that pseudarthrosis caused the fracture of the screw.The patient underwent a revision procedure to replace the fractured screw.No additional patient consequences were reported.

• Brand Name: RESPONSE UNIAXIAL PEDICLE SCREW
• 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 ; 5172670872
• MDR Report Key: 8016746
• MDR Text Key: 125382306
• Report Number: 3006460162-2018-00069
• Device Sequence Number: 1
• Product Code: OSH
• UDI-Device Identifier: 0084113210249
• UDI-Public: (01)0084113210249(10)041818-E
• 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: 10/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• 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: 00-1300-3650
• Device Lot Number: 041818-E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2018
• 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: 12 YR