MAUDE Adverse Event Report: TMJ IMPLANTS, INC. CHRISTENSEN DEVICE

Device Problem Malposition of Device (2616)

Patient Problems Unspecified Infection (1930); Pain (1994); Toxicity (2333)

Event Date 09/01/2013

Event Type  Injury  

Event Description

I had the christensen total joints implanted in 1994.I developed a staph infection and was on a picc line.The infection ate through my mandible and nerves.I had to have the implant removed.The pmma head was pressed against my fossa and went through my skull.The implant also caused metallosis, tremendous amount of pain and had to be replaced with a new jaw implant device.

• Brand Name: CHRISTENSEN DEVICE
• Type of Device: CHRISTENSEN DEVICE
• Manufacturer (Section D): TMJ IMPLANTS, INC.
• MDR Report Key: 3628173
• MDR Text Key: 3990407
• Report Number: MW5034427
• Device Sequence Number: 1
• Product Code: LZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability