MAUDE Adverse Event Report: MIZUHO OSI MTS SPINAL SURGERY TOP; OPERATING TABLE

Model Number	5943
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Crack (1135)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the carbon from the metal end of the table top came apart causing the patient to fall.One of the doctors caught the patient's head and there were currently no known injuries observed.There were no treatments or extended stay needed for the patient.Point of contract stated there was a 1' crack on the carbon, and they removed it from service.
Event or Problem Description
It was reported that during surgery the carbon from the metal end of the table top came apart causing the patient to fall.One of the doctors caught the patient's head and there were currently no known injuries observed.There were no treatments or extended stay needed for the patient.Point of contract stated there was a 1' crack on the carbon, and they removed it from service.
Additional Manufacturer Narrative
Based on the limited available information and per the analysis of internal historical data pertaining to the product, it was found that there were no preventative maintenance checks performed from manufacturer's end.Internal records show that only one table was delivered to this facility in the year 2004 and hence, we suspect that the spine top joints may have disbonded due to aging and corrosion.

• Brand Name: MTS SPINAL SURGERY TOP
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 15364355
• Report Number: 2921578-2022-00019
• Device Sequence Number: 6478257
• Product Code: JEA
• UDI-Device Identifier: 00842430105982
• UDI-Public: 00842430105982
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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
• Operator of Device: Health Professional
• Device Model Number: 5943
• Device Catalogue Number: 5943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2019
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown