MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS BLU (TM) PECTUS STABILIZER; PLATE, FIXATION, BONE

Catalog Number	78-8020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Extraskeletal ossification (1428)
Date of Event	12/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products below in the d10 narrative.D10: concomitant medical products, part (lot): - 78-6120 (28367).The customer has not indicated whether the product will be zimmer biomet for investigation, and the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that following an initial double pectus bar placement procedure, the patient required a revision to a single bar placement four (4) months later due to rotation of the upper bar.Five (5) months after the revision, the patient underwent an additional procedure to remove the pectus bar due to significant heterotopic calcification overlaying the sternum.No additional information or outcomes were provided.
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.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records and radiographs were provided and were reviewed by health care professionals.Review of the available images identified the following: two views of the chest dated 4 months postop demonstrate pectus implant with two separate bars in place.Of note, on the lateral exam, the sternum is noted superficial to the bars suggesting hardware failure.Ap chest dated 5 months postop demonstrates removal of the superior bar.Implant appears to be appropriately sized on the ap film.No other anatomical or implant failures were observed that would lead to a revision surgery.Heterotopic calcification was not confirmed from the images.The medical records show the patient had a pectus bi implant shift resulting in removal of one of the bars.The patient has a significant heterotopic calcification overlaying the sternum which appears to be a reaction to the bar.Metal allergy testing dates and outcomes were not available and infection testing and outcomes were not performed.Hyperintense collection posterior to the inferior sternal stagnant which may represent a postoperative fluid collection or new cartilaginous change.A definitive root cause cannot be determined.The reported event is confirmed, based on the provided x-rays and medical records.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: PECTUS BLU (TM) PECTUS STABILIZER
• 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: 21316045
• Report Number: 0001032347-2025-00074
• Device Sequence Number: 20945435
• Product Code: HRS
• UDI-Device Identifier: 00888233032834
• UDI-Public: (01)00888233032834(10)28990
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: 78-8020
• Device Lot Number: 28990
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Hispanic
• Patient Race: White