MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM; BONE PLATE

Model Number 400.834

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event is an unknown date in 2018.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2018, the patient underwent a debridement of surgical site with removal of retained hardware and bone and open reduction internal fixation (orif) of cranium due to infection.One (1) titanium low profile neuro strut plate, three (3) titanium low profile neuro burr hole cover, and sixteen (16) titanium low profile neuro screw self-drilling was removed due to local infection at the site.Patient initially injured self in a motor vehicular accident (mva) and was ejected from the car.Patient had multiple surgeries to multiple areas including her head and multiple debridements from the initial surgery on (b)(6) 2018.There was no surgical delay.Procedure outcome was successful.Patient is still in coma.This report is for one (1) ti low profile neuro screw self-drilling 4mm.This is report 9 of 10 for (b)(4).This complaint has been updated with the 10 of 10 devices.Please see the linked complaint (b)(4) which captures the additional 10 devices.

• Brand Name: TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8193963
• MDR Text Key: 131321502
• Report Number: 2939274-2018-55556
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 20887587045402
• UDI-Public: (01)20887587045402
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022012
• 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
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 400.834
• Device Catalogue Number: 400.834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 68