MAUDE Adverse Event Report: ORTHOPEDIATRICS, INC UNKNOWN ORTHOPEDIATRICS RESPONSE PEDICLE SCREW; UNKNOWN PEDICLE SCREW

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Post Operative Wound Infection (2446)

Event Date 05/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item: 00-1003-4001, response large set screw, lot: unknown, quantity: 19.Item: 00-1003-6001, response 5.5 mm rod, 500 mm, lot: unknown, quantity: 2.Item: 00-1300-2630, response 5.5/6.0 polyaxial pedicle screw 6.0 mm x 30 mm, lot: unknown, quantity: 9.Item: 00-1300-2635, response 5.5/6.0 polyaxial pedicle screw 6.0 mm x 35 mm, lot: unknown, quantity: 3.Item: 00-1300-2740, response 5.5/6.0 polyaxial pedicle screw 7.0 mm x 40 mm, lot: unknown.Item: 00-1300-3041, response adjustable cross connector small, lot: unknown.Item: 00-1300-5034, response 5.5/6.0 fixed cross connector, 34 mm, lot: unknown.Item: 00-1300-3735, response 5.5/6.0 polyaxial reduction pedicle screw 7, lot: unknown, quantity: 2.Item: 00-1300-3860, response 5.5/6.0 polyaxial reduction pedicle screw 8, lot: unknown.Item: 00-1300-3870, response 5.5/6.0 polyaxial reduction pedicle screw 8, lot: unknown.Item: 01-1300-3000, 1.25 mm rounded guide wire 100 mm length, lot: unknown, quantity: 2.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that following the placement of the response spine system, the patient underwent a revision procedure due to infection.A pedicle screw directly below an open wound was removed and replaced.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay corrections to initial report based on initial reporting of the event.Surgeon reported that the adverse event was not related to the device but was a result of the patient condition.H6 - device code: 2993.Method codes: 4114-4111.Result codes: 213.Conclusion codes: 50.

• Brand Name: UNKNOWN ORTHOPEDIATRICS RESPONSE PEDICLE SCREW
• Type of Device: UNKNOWN PEDICLE SCREW
• Manufacturer (Section D): ORTHOPEDIATRICS, INC; 2850 frontier drive; warsaw IN 46582
• MDR Report Key: 7579255
• MDR Text Key: 110404712
• Report Number: 3006460162-2018-00034
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 12 YR
• Patient Weight: 32