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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Burning Sensation (2146)
Date of Event	06/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (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: 0001032347-2020-00608.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 or Problem 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 or Problem 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
No further event information available at the time of this report.
Additional 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.

• Brand Name: PECTUS SYSTEM ELONGATED PECTUS STABILIZER
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10999115
• Report Number: 0001032347-2020-00607
• Device Sequence Number: 3944522
• Product Code: HRS
• UDI-Device Identifier: 00841036011093
• UDI-Public: 00841036011093
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K981789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-3801
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 12/30/2020; 05/27/2021
• Initial Report FDA Received Date: 12/13/2020
• Supplement Report FDA Received Date: 01/27/2021; 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR