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

Model Number 04.503.104.01

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

Patient Problems Unspecified Infection (1930); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight not available for reporting.Unknown when infection began.Additional product code: gxr.Implants removed on an unknown date.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient was implanted with a (peek implant) patient specific implant, matrixneuro x-plates (quantity of 4), matrixneuro straight plates (quantity of 2) and matrixneuro screws (quantity of 20) on (b)(6) 2018 for a cranioplasty.Patient developed infection and the implants were removed on an unknown date.There was no surgical delay.The type of infection is unknown.Patient will be implanted with another patient specific implant.The surgery date has not been scheduled.This complaint involves a total of 27 devices captured on three (3) complaint files.(b)(4).This report is 3 of 10 for (b)(4).

Manufacturer Narrative

Additional product codes: gwo, gxr.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient was implanted with a patient specific implant (psi) polyether ether ketone (peek) implant, four (4) matrixneuro x-plates, two (2) matrixneuro straight plates, and twenty (20) matrixneuro screws on (b)(6) 2018 for a cranioplasty.On unknown date, patient developed infection.Patient was returned to surgery on unknown date where the implants were removed.There was no surgical delay.The type of infection is unknown.Patient was not revised to additional hardware at that time.Patient was later revised to another psi implant on (b)(6) 2018.This report involves a total of 27 devices captured on three (3) report files: (b)(4).This report is for one (1) matrixneuro screw.This report is 3 of 10 for (b)(4).

Manufacturer Narrative

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.

• Brand Name: TI MATRIXNEURO 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7313846
• MDR Text Key: 101524805
• Report Number: 2939274-2018-50853
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587018324
• UDI-Public: (01)10887587018324(10)LOTNUMBERUNK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.503.104.01
• Device Catalogue Number: 04.503.104.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR