MAUDE Adverse Event Report: A&E MEDICAL CORPORATION A&E MEDICAL / THORECON¿ AUXILIARY CABLE PLATE KIT; PLATE, BONE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Hypersensitivity/Allergic reaction (1907); Inflammation (1932)

Event Date 02/22/2023

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Product code: ikd.Product name: cable, electrode.Concomitant medical products : item # 94-1400-04, lot 429742; a&e medical / thorecon¿ box cable plate kit (inc.Screws & cable), quantity 2.Item # unk, lot # unk; unknown 14 mm screw.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002242056-2023-00004, 0002242056-2023-00003, 0002242056-2023-00006.

Event Description

It is reported the patient was revised of a sternal construct due to abnormal tissue responses over the plate sites.The surgeon indicated the possibility of a metal allergy reaction within the tissue.At the time of the revision, the sternal healing had been achieved well.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It is further reported through medical records that the patient had an initial coronary artery bypass graft procedure.Subsequently, the patient underwent a superficial and deep wound debridement with removal of sternal plating system and vac placement surgery due to wound dehiscence, surgeon reported possible metal allergy reaction within the tissue, approximately three (3) months post-implantation.During the procedure the bone was found to be healthy and stable.There was inflammatory tissue noted around each sternal plate.No intraoperative complications were reported.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This report is being submitted to update additional information in section b4, b5, d6, g3, g6, h2, h6 and h10.

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 record(s) identified no deviations or anomalies during manufacturing.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.This report is being submitted to update additional information in section b4, b5, d4, g3, g6, h2, h3, h4, h6 and h10.

Event Description

No further event information is available at the time of this report.

• Brand Name: A&E MEDICAL / THORECON¿ AUXILIARY CABLE PLATE KIT
• Type of Device: PLATE, BONE
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer (Section G): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16598317
• MDR Text Key: 311928325
• Report Number: 0002242056-2023-00005
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10841291107187
• UDI-Public: (01)10841291107187(17)270803(10)24623
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 94-1500-04-S
• Device Lot Number: 424623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male