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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

Reference: (b)(4).Customer has indicated that the product is in process of being returned to orthopediatrics for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that following a posterior fusion surgery, the patient experienced back pain and clicking.It was discovered during the revision procedure that a set screw was loose.No additional patient consequences were reported.

• Brand Name: RESPONSE LARGE SET 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 ; 5742670872
• MDR Report Key: 8571189
• MDR Text Key: 143754574
• Report Number: 3006460162-2019-00015
• Device Sequence Number: 1
• Product Code: OSH
• UDI-Device Identifier: 00841132100103
• UDI-Public: (01)00841132100103(10)M69067-B
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• 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: 00-1003-4001
• Device Lot Number: M69067-B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2016
• 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: 17 YR