MAUDE Adverse Event Report: TIDI PRODUCTS LLC ZERO GRAVITY LOW FLOOR SYSTEM 6.5 FT ARM; APRON, LEADED

Model Number	ZGM-6-5H
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: on 12/08/2025, the customer requested a quote for a replacement zg balancer.The customer reported that there was some resistance when attempting to retract the lead apron.The customer noted that there was no visible damage to the sheathing around the cable.The cable had previously been upgraded on 02/12/2021.The affected device is a zgm-6-5h balancer, serial number (b)(6), manufactured in march 2014.The product will not be returned for evaluation an therefore, this event is reported based on the information provided by the customer.Based on the information provided, the reported resistance may be related to internal wear or mechanical components within the balancer assembly.Without the product for investigation, the root cause cannot be confirmed.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.User guide states: use safety confirm that system has been installed per the tidi products issued installation guide.Failure to maintain control of column, when raising or lowering, can result in personal injury or property damage.Do not attempt to relocate floor unit during a procedure.Incorrect system positioning or adjustment may cause personal injury or equipment damage.User manual is explicit in advising the customer to inspect for any missing or damaged components prior to use with a patient, and to not use the unit if any damage is found.Manufacturer reference file: (b)(4).
Event or Problem Description
Customer asked for quote for a replacement zg balancer, she stated there is some resistance when you are trying to retract the lead apron.No damage to the sheathing around the cable noticed by the customer.Cable was upgraded on 2/12/21 model: zgm-6-5h, serial#: (b)(6), manufactured 3-2014.

• Brand Name: ZERO GRAVITY LOW FLOOR SYSTEM 6.5 FT ARM
• Common Device Name: APRON, LEADED
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 23929577
• Report Number: 2182318-2025-00114
• Device Sequence Number: 13019063
• Product Code: EAJ
• UDI-Device Identifier: 00618125176250
• UDI-Public: 00618125176250
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ZGM-6-5H
• Device Catalogue Number: ZGM-6-5H
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown