MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS BLU PRBNT TI BAR 11IN; PLATE, FIXATION, BONE

Catalog Number	78-6110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pleural Effusion (2010); Pneumonia (2011)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent an initial nuss procedure.Subsequently, the patient was diagnosed with pneumonia and pleural effusion requiring chest tube placement and hospitalization.Attempts have been made, and no further information is available.
Additional Manufacturer Narrative
(b)(4).Procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Pneumonia is a well-known postoperative complication that typically requires medical intervention and possibly even hospitalization for more aggressive medical management.Within a two-hour postoperative window, the protective reflexes of the oropharyngeal passages are depressed, and the patient can aspirate.The reason for postoperative pneumonia is typically due to aspiration of subglottic secretions containing bacteria.Once the bacteria enter the respiratory tract, they can replicate and advance into aspiration pneumonia.Patient that has known history of respiratory or lung diseases such as copd, asthma, or are immune suppressed are at increased risk for developing this complication.While pneumonia is a collection of fluid within the lungs, pleural effusions are fluid collections in the outer spaces of the lungs requiring chest tube placement to drain the fluid from the pleural space.Both are procedural related complications resulting from intubation during the procedure and are considered hospital-acquired conditions.As the complaint indicates, a postoperative complication of pneumonia & pleural effusions developed, and medical intervention was required for treatment.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 BLU PRBNT TI BAR 11IN
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22671837
• Report Number: 0001032347-2025-00321
• Device Sequence Number: 15313503
• Product Code: HRS
• UDI-Device Identifier: 00888233032636
• UDI-Public: (01)00888233032636(10)26863
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K212841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 78-6110
• Device Lot Number: 26863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White