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 Code	Pain (1994)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: initial nuss procedure performed.Approximately one month prior to the revision procedure, xray confirmed there was no malposition of the bars.Four days prior to revision procedure, follow up with the patient reported chronic pain on left side of chest over stabilizer.Pain was rated 8 out of 10, with no relief found through pt, ice, heat, and lidocaine patch were used.Therefore, stabilizer was removed.Root cause was unable to be determined.The reported event is confirmed by provided medical records.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 or Problem Description
It was reported the patient underwent an initial nuss procedure.Subsequently, the patient was revised approximately five (5) months post-implantation due to pain.The stabilizer bar was removed.Attempts have been made, and no further information is available.

• 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: 22680467
• Report Number: 0001032347-2025-00338
• Device Sequence Number: 9663722
• Product Code: HRS
• UDI-Device Identifier: 00888233032636
• UDI-Public: (01)00888233032636(10)119610
• 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): 07/31/2025

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: 07/31/2025
• 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