NA 7210551Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 03596010513649), received between Nov 22, 2018 and Mar 11, 2026 — classified as 3 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Unstable” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Positioning Problem

  IT WAS REPORTED THAT DURING A TOTAL SHOULDER ARTHROSCOPY, IT WAS NOTICED THAT T MAX SHOULDER POSITIONER'S BEACH CHAIR WAS NOT RAISING PROPERLY AS IT WAS SUPPOSED TO BE. THE PROCEDURE WAS CANCELLED AND THE PATIENT WOKEN UP FROM ANESTHESIA. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575963 ↗
• MalfunctionMay 27, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROPLASTY, THERE WAS AN HYDRAULIC LEAK IN A T-MAX BEACH CHAIR. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES, AND USING A COMPETITOR BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400871 ↗
• MalfunctionDec 13, 2022Unstable; Unstable

  IT WAS REPORTED THAT DURING AN SHOULDER ARTHROSCOPY, A T-MAX II SHOULDER EXPOSURE POSITIONER´S HEAD PIECE DETACHED FROM THE OCTAGON SHAPED ROD THAT CONNECTS THE GOLD BALL, AND THEREFORE, IT WAS SWIVELING MID CASE, MEANING THAT THE TOP BALL AND THE GLUED IN OCTAGON SHAPED JOINT COMING OUT OF THE BALL CAME LOOSE. SURGERY CONTINUED WITHOUT ANY DELAY, WITH PART OF THE SURGERY STAFF HOLDING THE HEAD OF THE DEVICE FOR AROUND 20 TO 30 MINUTES, HOWEVER A BACK-UP DEVICE WAS REPORTED TO BE AVAILABLE AS WELL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15966521 ↗
• MalfunctionJun 27, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE T-MAX II WAS NOT HOLDING IN PLACE AT FULL 90. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12073141 ↗
• MalfunctionMay 24, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE T-MAX II HAD LEAKING FLUID FROM THE SEAL. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872800 ↗
• MalfunctionApr 29, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT CUSTOMERS WERE HAVING TROUBLES MOVING THE THAT T-MAX POSITIONER WAS FROM LEFT TO RIGHT DURING SET UP OR INSPECTION FOR AN UNKNOWN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO INJURIES, DELAYS OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11750603 ↗
• MalfunctionMar 24, 2021Unstable; Unstable

  IT WAS REPORTED THAT, DURING SETUP OR INSPECTION, THE T-MAX II SHOULDER EXPOSURE POSITIONER WAS NOT KEEPING THE HEIGHT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO DELAY NOR PATIENT INJURY. IT IS UNKNOWN WHAT PROCEDURE WAS BEING PERFORMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566628 ↗
• MalfunctionMar 11, 2021Break; Unstable; Break; Unstable

  IT WAS REPORTED THAT DURING A SHOULDER SCOPE USING A T-MAX SHOULDER POSITIONER, THE NURSE WAS ATTEMPTING TO PUSH THE PATIENT UP AND PUSHED AGAINST THE BACK REST AND BROKE THE SCREW. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO DELAYS OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11467000 ↗
• MalfunctionMar 3, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE T-MAX POSITIONER, BEACH CHAIR HYDRAULICS STOPPED WORKING. THE INCIDENT OCCURRED BEFORE THE PROCEDURE. THERE WAS NO DELAY AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404722 ↗
• MalfunctionFeb 1, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE T-MAX II, SHOULDER EXPOSURE POSITIONER SUSPENSION DID NOT WORK WHEN YOU GRAB THE SILVER HANDLE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11263930 ↗
• MalfunctionJan 26, 2021Unstable; Pressure Problem; Unstable; Pressure Problem

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, THE HYDRAULICS OF THE "T-MAX II, SHOULDER EXPOSURE POSITIONER" SLOWLY RELEASE WHEN UNDER PRESSURE AND THE TABLE FLATTENS OUT. THE POSITIONER COULD NOT REMAIN THE STIFF BEACH CHAIR POSITION WHEN THE PATIENT'S WEIGHT WAS ON IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY BY REPOSITIONING THE SAME FAULTY DEVICE. THE PATIENT WAS ALREADY ANESTHETIZED, BUT NO FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11232673 ↗
• MalfunctionJan 20, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE T-MAX II, SHOULDER EXPOSURE POSITIONER WAS BENT DURING SET UP FOR AN UNKNOWN PROCEDURE, PATIENT WAS ALREADY UNDER ANESTHESIA. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S DEVICE WITH NO DELAYS. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11205282 ↗
• MalfunctionJan 18, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE T-MAX II, SHOULDER EXPOSURE POSITIONER'S HYDRAULICS/ SUSPENSION DID NOT WORK DURING SET UP OR INSPECTION FOR A ROTATOR CUFF REPAIR. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY, DELAYS OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11185453 ↗
• MalfunctionJan 18, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SHOULDER EXPOSURE POSITIONER WAS BENT DURING SHOULDER ARTHROSCOPY. THE T-MAX BEACH CHAIR WAS POSITIONED ON THE OPERATING ROOM TABLE INCORRECTLY AND THE PROBLEM CAUSED A 4 H DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11183877 ↗
• MalfunctionDec 22, 2020Unstable; Unstable

  IT WAS REPORTED THAT DURING A SHOULDER CASE, TWO POSITIONER KNOBS WERE NOT WORKING PROPERLY. THE LONG ROD THAT RUNS DOWN THE CENTER OF THE DEVICE WAS LOCKED INTO PLACE THAT IT WAS STILL ABLE TO ROTATE SIDE TO SIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11056009 ↗
• MalfunctionDec 17, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE SHOULDER POSITIONER ARM BOARD IS COMING APART OF THE METAL PART. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11028752 ↗
• MalfunctionDec 3, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED T-MAX II, SHOULDER EXPOSURE POSITIONER WAS SLIPPING. IT IS UNKNOWN WHETHER THERE WAS A BACK UP AVAILABLE OR DELAY IN THE CASE AND IF THE EVENT HAPPENED DURING SURGERY. NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10939763 ↗
• InjuryNov 22, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY REPLACEMENT, IT WAS NOTICED THAT THE T-MAX BEACH CHAIR WAS TILTING BACKWARDS. THE STAFF GRABBED THE PATIENT IN ORDER TO PREVENT HIM FROM LANDING ON THE FLOOR. IT WAS REPORTED THAT THE LEFT TABLE LEG ASSEMBLY CAME OFF THE BED RAILING AND IT WAS ONLY SUPPORTING THE PATIENT¿S WEIGHT ON THE RIGHT PART OF THE TABLE ASSEMBLY. THE WOUND WAS CLOSED, THE PATIENT WAS PLACED IN A HOSPITAL BED IN ORDER TO ADJUST THE DEVICE AGAIN. IT WAS ALSO REPORTED THAT THE RIGHT TABLE LEG IS CURRENTLY AT A 20/25 DEGREES ANGLE. NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10881661 ↗
• MalfunctionNov 19, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, EXTERNAL TO THE PATIENT, THE T-MAX SHOULDER POSITIONER WENT OUT OF 350 POUND CAPACITY. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. NO DELAYS AND NOT OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10872032 ↗
• MalfunctionNov 11, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SHOULDER POSITIONER PISTONS WERE FROZEN. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10826137 ↗
• MalfunctionOct 28, 2020Unstable; Positioning Problem; Unstable; Positioning Problem

  IT WAS REPORTED THAT THE T-MAX II WAS NOT HOLDING THE POSITION. THE INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. NO DELAY REPORTED AND A BACKUP DEVICE WAS AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10747503 ↗
• MalfunctionOct 5, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING SURGERY THE HEADPIECE OF THE T MAX ON FIRST USE WAS VERY LOOSE, SO THE CONNECTION BETWEEN THE RUBBER HEADREST AND THE PLASTIC BACKING AND THE METAL ROD WAS NOT SECURE; THE PROCEDURE WAS COMPLETED USING ANOTHER METHOD; THERE IS NO INFORMATION REGARDING IF THERE WAS ANY DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10631380 ↗
• MalfunctionOct 5, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING SURGERY THE HEADPIECE OF THE T MAX ON FIRST USE WAS VERY LOOSE, SO THE CONNECTION BETWEEN THE RUBBER HEADREST AND THE PLASTIC BACKING AND THE METAL ROD WAS NOT SECURE; THE PROCEDURE WAS COMPLETED USING ANOTHER METHOD; THERE IS NO INFORMATION REGARDING IF THERE WAS ANY DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10631222 ↗
• MalfunctionSep 25, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SHOULDER EXPOSURE POSITIONER WAS LEAKING SOME OIL. NO CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10588363 ↗
• MalfunctionSep 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER A PROCEDURE, THE SHOULDER POSITIONER WAS LEAKING HYDRAULIC FLUID. NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10525960 ↗