MAUDE Adverse Event Report: KLS MARTIN SONICWELD RX

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Abscess (1690)

Event Date 04/01/2018

Event Type  Injury  

Event Description

Event: abscess.The pt developed an abscess 17 months after using sonicweld rx for midfacial fracture fixation.This event was severe and serious, requiring hospitalization and debridement.A causality was found between the bioresorbable implants used and the abscess.This was an unexpected adverse event.A debridement was performed following the use of intravenous antibiotics.This event lasted for 4 days before our medical intervention.This abscess was resolved and the pt was completely recovered without any compromised of the healing of fracture.

• Brand Name: SONICWELD RX
• Type of Device: SONICWELD RX
• Manufacturer (Section D): KLS MARTIN; GM
• MDR Report Key: 7457646
• MDR Text Key: 106661884
• Report Number: MW5076688
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Weight: 65