MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SYSTEM 12IN PECTUS SUPPORT BAR; PLATE, FIXATION, BONE

Model Number N/A

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

Patient Problems Erythema (1840); Pain (1994); Burning Sensation (2146)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00607.The event occurred in 2019.The implantation date was in 2018.Medical products: pectus system elongated pectus stabilizer, part# 01-3801, lot# ni.Pectus system 12in pectus support bar, part# 01-3712, lot# ni.

Event Description

It was reported an mri was abandoned due to heating at the implant site.The patient was undergoing an mri of the breast due to implant rupture and the patient had an existing pectus support bar implanted.The mri operator decided to perform the exam at 1.5 tesla magnet for the sake of safety.During the scan the patient experienced pain and heating in the chest.The exam was discontinued.The skin around the patient¿s sternum and under the breast was red and hot to the touch.Ice packs were applied to the chest wall.Attempts have been made but no further information has been provided.

Event Description

It was reported an mri was abandoned due to heating at the implant site.The patient was undergoing an mri of the breast due to silicone implant rupture and the patient has an existing pectus support bar implanted.The mri operator decided to perform the exam at 1.5 tesla magnet for the sake of safety.During the scan the patient experienced pain and heating in the chest.The exam was discontinued.The skin around the patient¿s sternum and under the breast was red and hot to the touch.Ice packs were applied to the chest wall.The patient has not returned for further breast mri but has undergone hip and brain mris without incident.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.This report is being submitted to update additional information in section a1, a2, b3, b5, b7, h2, h6 and h10.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided for these items.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: PECTUS SYSTEM 12IN PECTUS SUPPORT BAR
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10999103
• MDR Text Key: 221233379
• Report Number: 0001032347-2020-00608
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036011024
• UDI-Public: 00841036011024
• Combination Product (y/n): N
• PMA/PMN Number: K972420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-3712
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR