MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. PROAXIS SPINAL SURGERY TABLE (INT'L); OPERATING TABLE

Model Number	6988A--GT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Swelling (2091); Pressure Sore/Ulcer (2326); Skin Tears (2516)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was positioned prone for t4-pelvis fusion utilising the standard proaxis spine assembly (open frame/spars) configured with torso trolley, arm boards, chest/pelvic bolsters and leg support.All items were covered prior to the procedure with the recommended osi shear protect consumables to minimise risk of skin injury.Postoperatively, the client presented with pressure related sores in the following areas - eyelids, chin, left precordial region, right iliac crest (left and right hips).The left and right hands/wrist also had some swelling and blistering and the right calf sustained a grade 2 tear.It was noted that bmi and length of case (up to 14 hours) could have been contributing factors.
Additional Manufacturer Narrative
Unable to determine if the patient had comorbidities that could have contributed to the problem.Advised the distributor to discuss the owner's manual positioning instructions with the customer.Further information received from the distributor revealed that this is the same incident as that reported in 2921578-2018-00038, 2921578-2019-00015 and 2921578-2019-00016.
Event or Problem Description
Patient was positioned prone for t4-pelvis fusion utilising the standard proaxis spine assembly (open frame/spars) configured with torso trolley, arm boards, chest/pelvic bolsters and leg support.All items were covered prior to the procedure with the recommended osi shear protect consumables to minimise risk of skin injury.Postoperatively, the client presented with pressure related sores in the following areas - eyelids, chin, left precordial region, right iliac crest (left and right hips).The left and right hands/wrist also had some swelling and blistering and the right calf sustained a grade 2 tear.It was noted that bmi and length of case (up to 14 hours) could have been contributing factors.
Additional Manufacturer Narrative
Unable to determine if the patient had comorbidities that could have contributed to the problem.Advised the distributor to discuss the owner's manual positioning instructions with the customer.
Event or Problem Description
Patient was positioned prone for t4-pelvis fusion utilising the standard proaxis spine assembly (open frame/spars) configured with torso trolley, arm boards, chest/pelvic bolsters and leg support.All items were covered prior to the procedure with the recommended osi shear protect consumables to minimise risk of skin injury.Postoperatively, the client presented with pressure related sores in the following areas - eyelids, chin, left precordial region, right iliac crest (left and right hips).The left and right hands/wrist also had some swelling and blistering and the right calf sustained a grade 2 tear.It was noted that bmi and length of case (up to 14 hours) could have been contributing factors.

• Brand Name: PROAXIS SPINAL SURGERY TABLE (INT'L)
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 8358172
• Report Number: 2921578-2019-00010
• Device Sequence Number: 11326069
• Product Code: JEA
• UDI-Device Identifier: 00842430106880
• UDI-Public: 00842430106880
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2019

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: 6988A--GT
• Device Catalogue Number: 6988A--GT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2019
• Supplement Date Received by Manufacturer: 04/02/2019; 04/02/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 04/23/2019; 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other