MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SYSTEM 15IN PECTUS SUPPORT BAR; PLATE, FIXATION, BONE

Model Number N/A

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

Patient Problem Burning Sensation (2146)

Event Date 11/15/2020

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: 0001032347-2020-00605.Medical products: pectus system 14in pectus support bar, part# 01-3714, lot# ni.Pectus system 15in pectus support bar, part# 01-3715, lot# ni.(b)(4).

Event Description

It was reported a cardiac mri was abandoned after the patient experienced a burning sensation at the site of their pectus support bar.One (1) month following implantation of two (2) pectus support bars, the patient went in for a cardiac mri.The patient felt some heating after the first localizer.Some other quicker localizers that produce less specific absorption rate were attempted and the patient indicated they felt heating.The decision was made to discontinue the scan.The patient indicated that the burning sensation occurred at the sides of the chest where the ends of the bars are located.Attempts have been made but no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported a cardiac mri was abandoned after the patient experienced a burning sensation at the site of their pectus support bar.One (1) month following implantation of two (2) pectus support bars, the patient went in for a cardiac mri.The patient felt some heating after the first localizer.Some other quicker localizers that produce less specific absorption rate were attempted and the patient indicated they felt heating.The decision was made to discontinue the scan.The patient indicated that the burning sensation occurred at the sides of the chest where the ends of the bars are located, and that the heating occurred only when the scanner was acquiring an image.The patient did not experience any discomfort following the mri.The patient has not returned for a cardiac mri due to heating of the implant.It was reported that no additional information was available.

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 15IN PECTUS SUPPORT BAR
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10999108
• MDR Text Key: 221240708
• Report Number: 0001032347-2020-00606
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036011055
• UDI-Public: 00841036011055
• 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,user faci
• 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: 01-3715
• Device Lot Number: UNKNOWN
• 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: 25 YR