MAUDE Adverse Event Report: MIZUHO OSI JACKSON SPINAL & IMAGING TABLE; OPERATING TABLE

Model Number JST-2000

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

Patient Problem Pressure Sores (2326)

Event Date 12/17/2020

Event Type  Injury  

Event Description

Literature citation: an exploratory study of risk factors for pressure injury in patients undergoing spine surgery anesth pain med.2021;16(1):108-115.Published online december 17, 2020.Doi: https://doi.Org/10.17085/apm.20081.Electronic medical records of 663 patients who underwent spinal surgery between march 2016 and may 2018 were analyzed.The primary outcome was observed to be the occurence of pressure injuries.Patients aged 18 years and older, of both sexes, undergoing elective or emergency, prone position, lumbar or thoracic, spinal surgeries between march 2016 and may 2018 on jackson spinal imaging table (jst-2000, mizuho osi) were included in the study.Among 663 patients, the incidence of all stages of pressure injury was 5.9%.The face and inguinal regions were the most injured sites (both 28.6%).The pressure injury group showed a 13% longer hospitalization period.Preoperative plasma concentration of protein was associated with 0.5-fold lower pressure injury (or: 0.50; 95% ci: 0.27 to 0.95; p = 0.034).Comparing patient populations with and without occurrence of intraoperative pressure injury, the pressure injury group showed a 13% longer hospitalization period and a 3% lower protein plasma concentration than the non-pressure injury group.We found that a lower preoperative serum protein level is significantly associated with intraoperative pressure injury occurrence during spinal surgery.The higher preoperative plasma concentration of protein was associated with 0.5-fold lower risk of pressure injury (or: 0.50; 95% ci: 0.27 to 0.95; p = 0.034).In the cases of pressure injuries occurring within a relatively short period of time as like intraoperative period, preoperative risk factors such as plasma protein level rather than intraoperative factors may be more closely related to the pressure injury.

Manufacturer Narrative

Literature citation: an exploratory study of risk factors for pressure injury in patients undergoing spine surgery anesth pain med.2021;16(1):108-115.Published online december 17, 2020.Doi: https://doi.Org/10.17085/apm.20081.Following the investigation, the author was unable to provide additional information about the patients in scope of the report.The literature report was based on retrospective analysis of the medical records of 663 patients that underwent spinal surgery between march 2016 and may 2018.Pressure injuries (49) occured in 39 patients out of which 11 injuries were stage-2 on the face that we consider as serious and 38 injuries were either stage-1 or stage-2 on various parts of the body considered non serious.The report concluded that certain intraoperative and preoperative risk factors could have contributed to the occurence of observed pressure injuries.

• Brand Name: JACKSON SPINAL & IMAGING TABLE
• Type of Device: 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 94587-1234 ; 5104291500
• MDR Report Key: 15332515
• MDR Text Key: 299036591
• Report Number: 2921578-2022-00017
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: JST-2000
• Device Catalogue Number: JST-2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian