MAUDE Adverse Event Report: BIOMET MICROFIXATION, INC PECTUS SYSTEM; PLATE, FIXATION, BONE

Model Number 01-3715

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

Patient Problem Burning Sensation (2146)

Event Date 11/15/2020

Event Type  No Answer Provided  

Event Description

Young adult patient has a biomet microfixation device implanted in his chest.Per the manufacturer this implant is conditional to 3t.The patient was in mri for a cardiac mri.The patient was scanned on a 1.5t scanner in normal mode.The patient was instructed that if he felt any warming or heating in the site of his implant to let us know.After the first localizer, the patient said he did feel some heating in his chest.We tried a couple quicker localizers that produce less sar (specific absorption rate), but the patient said he felt some heating with those, although a little less.At this time, the decision was made to end the exam for fear of burning the patient.He said he felt the heating only while the scanner was acquiring an image.As we were pulling the patient out of the scanner he was asked where specifically he had felt the heating and he pointed to the left and right of his chest.We explained to the patient why it was necessary to stop the exam and he understood.He had no discomfort following the mri.I called the nurse to let her know why the exam was aborted.I updated the implant mri safety information to include that despite the manufacturer saying it is conditional to 3t, the patient felt heating on a 1.5t scanner in normal mode.Below is the mri safety info provided by the manufacturer."the pectus support bar system is mr-conditional according to the terminology specified in the astm international, designation: f2503-05.Non-clinical testing demonstration that the pectus support bar system bar is mr conditional.A patient with this implant can be scanned safely immediately after placement under following conditions: static magnetic field of 3-tesla or less and a maximum spatial gradient magnetic field of 720-gauss/cm".Manufacturer response for biomet micro fixation zimmer, implant sternum 15 in bar support pectus lorenz - (b)(4) (per site reporter): the mri manager reached out to the manufacturer for this zimmer.The manager received in return the ifu for this device, which states the same information about being conditional to 3t.It mentions specifically that a patient can have mri chest and abdomen studies.There is no further information on wait time after implantation, no restricted zones mentioned.The (b)(4) area representative returned my call and asked me to write an email to him with all the information so he forward it to the appropriate people.

• Brand Name: PECTUS SYSTEM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION, INC; 1520 tradeport dr.; jacksonville FL 32218
• MDR Report Key: 10903299
• MDR Text Key: 218216400
• Report Number: 10903299
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Device Operator: No Information
• Device Model Number: 01-3715
• Device Catalogue Number: 01-3715
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8760 DA