MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; BONE PLATE

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Itching Sensation (1943)

Event Type  Injury  

Manufacturer Narrative

This report is for one (1) unknown matrixneuro mesh/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device implanted 15 years ago in 2003; exact date is unknown.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 an unknown date, the unknown metal mesh tape covering the patient's skull for fifteen (15) years broke and protruded through the skin.The patient was initially implanted with an unknown metal mesh tape in 2003 approximately 15 years ago after an accident of falling out of a pickup.Patient was seen on (b)(6) 2018 and reported that he had an itching bump for last 7-8 months and for 6 months he noted there was something coming through the skin.Patient reported no fevers, no active infections.The manufacturer of the device was unknown.No other information provided.This report is for one (1) unknown matrixneuro mesh.This is report 1 of 1 for (b)(4).

Event Description

This should be closed as a non-product issue (npi)as there is no evidence that the metal mesh tape is a synthes device.This is not a synthes psi implant.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The initial complaint was reviewed and found not reportable.This should be closed as a non-product issue (npi)as there is no evidence that the metal mesh tape is a synthes device.This is not a synthes psi implant.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.

• Type of Device: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8307825
• MDR Text Key: 135150440
• Report Number: 2939274-2019-56322
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 74