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

Catalog Number	01-3801
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Skin Discoloration (2074)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2 - report source - foreign: china.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the patient underwent an initial implantation.The patient started experiencing pain and redness to the skin due to a possible allergic reaction.Subsequently, the patient was revised approximately twenty days post-implantation and all products were removed.The patient was implanted with competitor products.
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.The following sections were updated: b5; d9; g3; h2; h3; h6; h10; and h11.The reported event could not be confirmed due to lack of information.Medical records were not provided.An investigation was conducted on the returned products and customer provided pictures.Only the two reported 01-3801 stabilizers were returned.The reported 01-3714 was not returned.The implants all show signs of use including marking and scratching on the product surfaces as well as blood in the customer provided picture.The device history record was reviewed and no discrepancies relevant to the reported event were found.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 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 and/or corrected information.Updated: h10.

• Brand Name: ELONGATED 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: 24661328
• Report Number: 0001032347-2026-00075
• Device Sequence Number: 5042190
• Product Code: HRS
• UDI-Device Identifier: 00841036011093
• UDI-Public: (01)00841036011093(11)250507(10)67347097
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K981789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2026

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: 01-3801
• Device Lot Number: 67347097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 04/20/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/15/2026; 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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 Sex: Unknown