NA 511.701Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,164 adverse event reports that list this exact device (DI 10886982237644), received between Nov 21, 2017 and Sep 21, 2026 — classified as 1 injury, 2,163 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (875 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 2,164 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Fragmentation; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846757 ↗
• MalfunctionSep 16, 2026Mechanical Jam; Physical Resistance/Sticking

  It was reported that during service and evaluation, it was determined that the compact air drive device had a sticky trigger. It was noted in the service order that the reverse mode became stuck. This event did not occur during surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788056 ↗
• MalfunctionSep 1, 2026Mechanical Jam; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50544285 ↗
• MalfunctionAug 27, 2026Physical Resistance/Sticking

  It was reported that the COMPACT AIR DRIVE II device reverse trigger was stuck. It was not reported if the device was used in surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026.All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50477185 ↗
• MalfunctionMay 19, 2026Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE COMPACT AIR DRIVE DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE REVERSE MODE DID NOT FUNCTION. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222187 ↗
• MalfunctionMay 1, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE COMPACT AIR DRIVE II DEVICE HAD ISSUES WITH THE LOCKING BUTTON. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056593 ↗
• MalfunctionApr 27, 2026Complete Loss of Power

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE COMPACT AIR DRIVE DEVICE DID NOT OPERATE UNDER LOAD. IT WAS REPORTED THAT WHEN PRESSURE WAS APPLIED, IT ROTATED, BUT WHEN ATTEMPTING TO SAW/MILL, IT WOULD STOP WORKING. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24999334 ↗
• MalfunctionApr 24, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE REVERSE MODE BUTTON OF THE COMPACT AIR DRIVE DEVICE WAS STUCK. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN APRIL OF 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24987767 ↗
• MalfunctionApr 13, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE REVERSE TRIGGER OF THE COMPACT AIR DRIVE DEVICE DID NOT WORK. IT WAS REPORTED THAT THE TRIGGER WAS STUCK. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858242 ↗
• MalfunctionApr 12, 2026Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE COMPACT AIR DRIVE DEVICE HAD COSMETIC DAMAGE ¿ WORN, THE REVERSE LOCKING MECHANISM WAS BLOCKED ¿ WILL NOT REVERSE, WILL NOT RUN, MODE SWITCH RESISTANCE WAS TOO LOW, AND MOVING PARTS OF THE TRIGGER OF THE DEVICE DID NOT MOVE SMOOTHLY. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK FOR STICKY TRIGGER, CHECK REVERSE LOCKING MECHANISM WITH OSCILLATING SAW ATTACHMENT, CHECK FREE MOVEMENT OF SOFT-MODE SWITCH, CHECK FUNCTION OF DEVICE, AND CHECK POWER WITH POWER TEST BENCH. IT WAS NOTED IN THE SERVICE ORDER THAT THE EQUIPMENT DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24853206 ↗
• MalfunctionApr 8, 2026Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE HANDPIECE DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821926 ↗
• MalfunctionApr 2, 2026Complete Loss of Power

  IT WAS REPORTED THAT POST SURGERY, IT WAS OBSERVED THAT THE HANDPIECE DEVICE STOPPED DURING PERFORMANCE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF SURGICAL DELAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766145 ↗
• MalfunctionMar 18, 2026Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE COMPACT AIR DRIVE DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT THE DEVICE WAS NOT WORKING PROPERLY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629215 ↗
• MalfunctionMar 11, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE COMPACT AIR DRIVE DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS BLOCKED CAUSING IT NOT TO WORK AT ALL. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570340 ↗
• MalfunctionFeb 19, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE COMPACT AIR DRIVE DEVICE HAD A STICKY TRIGGER, WOULD NOT RUN, MOVING PARTS OF THE DEVICE DID NOT MOVE SMOOTHLY, AND HAD COMPONENT DAMAGE. IT WAS NOTED THAT THE DEVICE HAD INSUFFICIENT POWER CAUSING THE INSTRUMENT TO RUN SLOW, AND/OR WITH LOWER ENERGY., AND THE HANDPIECE WAS JAMMED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK CANNULATION, CHECK FREE MOVEMENT OF SOFT MODE SWITCH, CHECK FOR STICKY TRIGGER, CHECK THE FUNCTION OF THE DEVICE, AND CHECK POWER WITH POWER TEST BENCH. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24392655 ↗
• MalfunctionFeb 10, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE COMPACT AIR DRIVE DEVICE TRIGGER WAS LOCKED. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303502 ↗
• MalfunctionFeb 9, 2026Break; Complete Loss of Power

  IT WAS REPORTED THAT THE COMPACT AIR DRIVE DEVICE HAD A BURSTING NOISE WHEN THE UNIT WAS CONNECTED TO A HOSE AND OPERATED. THE HOSE BURST WHEN THE UNIT WAS OPERATED THEN DID NOT WORK. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292136 ↗
• MalfunctionFeb 4, 2026Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE COMPACT AIR DRIVE DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260121 ↗
• MalfunctionFeb 4, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE COMPACT AIR DRIVE DEVICE SWITCH MALFUNCTIONED. DURING PRE-REPAIR ASSESSMENT WAS CONFIRMED THAT TRIGGER WAS STICKY. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258139 ↗
• MalfunctionJan 28, 2026Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE COMPACT AIR DRIVE DEVICE TRIGGER WAS STICKY. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE SAFETY AND REVERSE MODE DID NOT FUNCTION. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203517 ↗
• MalfunctionJan 26, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE COMPACT AIR DRIVE DEVICE HAD A STICKY TRIGGER AND THE REVERSE LOCKING MECHANISM WAS BLOCKED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177100 ↗
• MalfunctionJan 15, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE COMPACT AIR DRIVE DEVICE REVERSE MODE WAS STUCK. DURING FURTHER FOLLOW UP, THE REPORTER STATED THAT THE PROBLEM WAS THAT THE SAFETY PIN WAS STRUCK THEN IT CAUSED TO THE DEVICE REVERSE DOES NOT FUNCTION. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079655 ↗
• MalfunctionDec 18, 2025Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE COMPACT AIR DRIVE DEVICE HAD INSUFFICIENT/LOW POWER, AND A STICKY TRIGGER. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR STICKY TRIGGER AND CHECK THE POWER WITH THE POWER TEST BENCH. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23841256 ↗
• MalfunctionDec 17, 2025Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE COMPACT AIR DRIVE DEVICE HAD A STICKY TRIGGER AND WOULD NOT RUN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK REVERSE LOCKING MECHANISM WITH OSCILLATING SAW ATTACHMENT II, CHECK FOR STICKY TRIGGER, CHECK FUNCTION OF DEVICE AND CHECK POWER WITH POWER TEST BENCH. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826645 ↗
• MalfunctionNov 24, 2025Noise, Audible; Complete Loss of Power; Noise, Audible; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE COMPACT AIR DRIVE DEVICE WAS MAKING EXCESSIVE NOISE, MOVING PARTS OF THE DEVICE DID NOT MOVE SMOOTHLY, HAD COMPONENT DAMAGE, AND WAS LEAKING AIR. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK THE ATTACHMENT COUPLING, CHECK ATTACHMENT COUPLING WITH OSCILLATING DRILL ATTACHMENT, CHECK FOR NOTICEABLE UNTRUE RUNNING, CHECK FOR NOTICEABLE NOISE, CHECK STARTING BEHAVIOR, AND CHECK FOR AIR LEAK. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT HAVE ELECTROMOTIVE FORCE, WAS NOT FUNCTIONING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630925 ↗