MAUDE Adverse Event Report: UNKNOWN UNKNOWN GAMMA KNIFE AND RADIATION PROCEDURE/UNKNOWN STIMULATOR; SYSTEM, RADIATION THERAPY, RADIONUCLIDE

Device Problems Break (1069); Insufficient Information (3190); Device Fell (4014)

Patient Problems Necrosis (1971); Loss of Vision (2139)

Event Type  Injury  

Event Description

The patient reported they received some sort of gamma knife procedure in 1999 and they believed that the radiation exposure caused them to have osteoradionecrosis of the mandible which caused them to lose part of their jaw, all of their lower teeth, and one eye.The patient also reported they had some sort of dbs procedure in 2001 during which they removed 3 parts of the patient's skull and that someone dropped the computer and broke it before the procedure could happen, post incision.The patient reported that the stimulator had been removed from the market because it was unsafe.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN GAMMA KNIFE AND RADIATION PROCEDURE/UNKNOWN STIMULATOR
• Type of Device: SYSTEM, RADIATION THERAPY, RADIONUCLIDE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17533026
• MDR Text Key: 321143753
• Report Number: MW5139932
• Device Sequence Number: 1
• Product Code: IWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1