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

Model Number	ZGM-6-5H
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: without the return of the device and additional information, the complaint cannot be confirmed, nor can root cause be positively determined.The root cause is for split in the lead is unknown at this time.The body shield is 10 years old, so it is unlikely that a manufacturing issue contributed to the failure.There was no patient or caregiver injury reported as a result of this event.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Per the instructions for use (ifu) ¿a thorough inspection of equipment should be performed, after each service call, prior to releasing the equipment for use.¿ additionally, ¿the zero-gravity system requires annual preventative maintenance, inspection, and general cleaning throughout its life.¿ manufacturer reference file:(b)(4).
Event or Problem Description
1/15/26-customer asked for quote to replace the zero gravity body shield as it did not pass the x-ray check as it was discovered that there is a large split in the lead model: zgm-6-5h serial#: (b)(6) manufactured 11-2016.

• Brand Name: ZERO GRAVITY FLOOR SYSTEM 6.5' 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: 24318649
• Report Number: 2182318-2026-00005
• Device Sequence Number: 5650300
• Product Code: EAJ
• UDI-Device Identifier: 00618125176250
• UDI-Public: 00618125176250
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/15/2026

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
• Device Lot Number: 593489-03
• 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: 01/15/2026
• Initial Report FDA Received Date: 02/11/2026
• 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