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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Hypersensitivity/Allergic reaction (1907); Inflammation (1932)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Additional 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); item # 94-1500-04-s, lot 424623; a&e medical / thorecon¿ auxiliary cable plate kit (inc.Screws & cable); 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, 0002242056-2023-00005, 0002242056-2023-00006.
Event or Problem 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.
Additional Manufacturer Narrative
This report is being submitted to update additional information in section b4, b5, d6, g3, g6, h2, h6 and h10.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem 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.
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 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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: A&E MEDICAL / THORECON¿ BOX CABLE PLATE KIT
• Common Device Name: 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: 16598330
• Report Number: 0002242056-2023-00003
• Device Sequence Number: 5311070
• Product Code: JEY
• UDI-Device Identifier: 10841291107224
• UDI-Public: (01)10841291107224(17)271025(10)429742
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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,Followup,Followup
• Report Date (Section B): 06/30/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 94-1400-04
• Device Lot Number: 429742
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 03/27/2023; 04/12/2023; 06/21/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 04/25/2023; 05/07/2023; 06/30/2023
• Date Device Manufactured: 10/25/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male