MAUDE Adverse Event Report: ORTHOPEDIATRICS UNKNOWN ORTHOPEDIATRICS LOCKING SCREW

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 10/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical device - catalog number: 00-0907-0103, 90 degree infant locking proximal femoral plate, 6mm offset, 3-hole, lot number: unknown.Customer has indicated that the product will not be returned to orthopediatrics for investigation as it was retained by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 3006460162-2017-00029.

Event Description

It was reported that following a proximal femoral osteotomy procedure, the patient was revised due to locking screws backing out of the bone.It was noted that during pre-operative planning the surgeon intended to use a 110 degree plate.After the initial cuts were made and bone prepped for a 110 degree plate, he decided to implant a 90 degree plate to achieve more correction.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 part and lot number of devices involved in the incident is unknown.Device history record 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.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.

• Brand Name: UNKNOWN ORTHOPEDIATRICS LOCKING SCREW
• Type of Device: UNKNOWN ORTHOPEDIATRICS LOCKING SCREW
• Manufacturer (Section D): ORTHOPEDIATRICS; 2850 frontier drive; warsaw IN 46582
• Manufacturer (Section G): ORTHOPEDIATRICS; 2850 frontier drive; warsaw IN 46582
• Manufacturer Contact: leigh jessop ; 2850 frontier drive; warsaw, IN 46582 ; 5742670872
• MDR Report Key: 7040936
• MDR Text Key: 92319609
• Report Number: 3006460162-2017-00028
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR