OPRA Implant System 1288Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 07340152100634), received between Feb 20, 2018 and Mar 3, 2026 — classified as 7 injuries, 102 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (95 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 109 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Detachment of Device or Device Component

  ON (B)(6) 2026: INTEGRUM RECEIVED INFORMATION THAT AXOR II UNIT (B)(6) HAS DETACHED FROM THE PROSTHESIS. NO INJURIES REPORTED. TECHNICAL INVESTIGATION OF UNIT (B)(6) PERFORMED. THE UNIT ARRIVED CONTAMINATED AND VERY DIRTY, THE INITIAL FUNCTIONAL TESTS COULD THEREFORE NOT BE PERFORMED. THE UNIT WAS CLEANED, AND AFTER CLEANING THE UNIT WAS FUNCTIONALLY TESTED ACCORDING TO SPECIFICATION WITH APPROVED RESULTS. THE ROOT CAUSE TO THE ISSUE IS ASSESSED AS INSUFFICIENT CLEANING. A FEEDBACK REPORT HAS BEEN PROVIDED TO THE CUSTOMER HIGHLIGHTING THE IMPORTANCE OF CLEANING THE AXOR II ACCORDING TO THE IFU, AND THAT THE AXOR II SHOULD NOT BE USED IF A STABLE CONNECTION CANNOT BE ACHIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494825 ↗
• MalfunctionFeb 19, 2026Detachment of Device or Device Component

  2026-01-22: INTEGRUM WAS INFORMED THAT AXOR II UNIT (B)(6) HAS FALLEN OFF FROM THE ABUTMENT. NO INJURY REPORTED. THE UNIT HAS NOT YET BEEN RECEIVED, HENCE NO TECHNICAL INVESTIGATION PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24386107 ↗
• MalfunctionFeb 6, 2026Detachment of Device or Device Component

  2026-01-07: INTEGRUM WAS INFORMED THAT AXOR II UNIT (B)(6) HAS FALLEN OFF FROM THE ABUTMENT. NO INJURY REPORTED. THE UNIT HAS NOT YET BEEN RECEIVED, HENCE NO TECHNICAL INVESTIGATION PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277827 ↗
• MalfunctionDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(6) 2025: INTEGRUM HAS BEEN INFORMED THAT AXOR II UNIT (B)(6) HAS FALLEN OFF FROM THE ABUTMENT. NO INJURY REPORTED. TECHNICAL INVESTIGATION HAS NOT YET BEEN PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848036 ↗
• MalfunctionNov 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  OCT. 17TH, 2025: INTEGRUM RECEIVED UNIT (B)(6) WITH A REPORT FORM STATING THAT THE AXOR II HAS LOOSENED FROM THE ABUTMENT CAUSING THE PATIENT TO FALL MULTIPLE TIMES. NO INJURIES REPORTED. THE DATE OF EVENT IS UNKNOWN. MANUFACTURING INVESTIGATION PERFORMED, THE UNIT HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. NOV. 13TH, 2025: TECHNICAL INVESTIGATION OF UNIT (B)(6) PERFORMED. DURING THE INVESTIGATION THE DEVICE FUNCTIONS WERE TESTED AND COMPONENTS INSPECTED. THE REPORTED ISSUE COULD NOT BE REPLICATED; THE DEVICE PASSED THE MANUFACTURER'S TESTS RELATED TO GRIPPING FUNCTION. THE GUIDE SCREWS DISCOVERED TO HAVE LOCTITE FAILURE; HOWEVER, THE SCREWS WERE NOT BACKED OUT TO CAUSE ANY OBSTRUCTION ON FUNCTIONALITY OF DEVICE. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE ESTABLISHED. DURING SERVICE LOCTITE WAS REAPPLIED, THE DEVICE WAS THOROUGHLY CLEANED AND FUNCTIONALLY TESTED ACCORDING TO SPECIFICATION WITH APPROVED RESULTS. INTEGRUM WILL INFORM THE CLINIC ON THE IMPORTANCE OF DONNING THE AXOR II ACCORDING TO THE IFU TO ENSURE A STABLE CONNECTION, AND THAT THE DEVICE SHALL NOT BE USED IF A STABLE CONNECTION CANNOT BE ACHIEVED.

  Patient problems: Fall

  MAUDE report 23554978 ↗
• MalfunctionNov 3, 2025Mechanical Problem; Mechanical Problem

  OCT. 14 2025: INTEGRUM RECEIVED INFORMATION THAT A PATIENT'S AXOR II (B)(6) RELEASED IN BENDING AND ROTATION DURING USE AND CAUSED THE PATIENT TO FALL. NO INJURIES REPORTED. THE DATE OF THE EVENTS IS UNKNOWN. MANUFACTURING INVESTIGATION PERFORMED, BATCH DOCUMENTATION REVIEWED. NO DEVIATIONS FOUND, THE DEVICE HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION, INCLUDING FUNCTIONALLY TESTED WITH PASS RESULT AS PART OF FINAL RELEASE. THE UNIT HAS NOT BEEN SENT FOR ANNUAL SERVICE SINCE ITS INITIAL RELEASE 2023. OCT. 24 2025: TECHNICAL INVESTIGATION OF UNIT (B)(6) PERFORMED. DURING THE INVESTIGATION THE DEVICE FUNCTIONS WERE TESTED AND COMPONENTS INSPECTED. THE REPORTED ISSUES COULD BE REPLICATED; THE BENDING AND ROTATION RELEASES VALUES WERE BELOW SPECIFICATION DUE TO DIRT AND WEAR OF COMPONENTS. DURING SERVICE, WORN COMPONENTS WERE REPLACED, THE UNIT WAS CLEANED AND THE RELEASE MECHANISMS CALIBRATED. THE UNIT WAS FUNCTIONALLY TESTED ACCORDING TO SPECIFICATION WITH APPROVED RESULTS. SINCE UNIT (B)(6) HAS NOT BEEN SENT FOR ANNUAL SERVICE (WHICH INCLUDES CHECK OF THE RELEASE FUNCTIONS) ACCORDING TO THE IFU, THE CONCLUSION OF THE INVESTIGATION IS THAT THE ROOT CAUSE IS INSUFFICIENT MAINTENA

  Patient problems: Fall

  MAUDE report 23447966 ↗
• MalfunctionOct 31, 2025Mechanical Problem; Mechanical Problem

  ON OCT. 16 2025: INTEGRUM RECEIVED INFORMATION THAT A PATIENT'S AXOR II (I9069) RELEASED IN BENDING AND ROTATION DURING USE AND CAUSED THE PATIENT TO FALL. NO INJURIES REPORTED. THE DATE OF THE EVENTS IS UNKNOWN. MANUFACTURING INVESTIGATION PERFORMED, BATCH DOCUMENTATION REVIEWED. NO DEVIATIONS FOUND, THE DEVICE HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION, INCLUDING FUNCTIONALLY TESTED WITH PASS RESULT AS PART OF FINAL RELEASE. OCT. 27 2025: TECHNICAL INVESTIGATION OF UNIT I9069 PERFORMED. DURING THE INVESTIGATION THE DEVICE FUNCTIONS WERE TESTED AND COMPONENTS INSPECTED. THE REPORTED ISSUES COULD BE REPLICATED ONLY FOR ROTATION RELEASE WHICH HAD VALUES BELOW SPECIFICATION. THE ROOT CAUSE COULD NOT BE ESTABLISHED. THE BENDING RELEASE WAS WITHIN SPECIFICATION. DURING SERVICE, THE UNIT WAS CLEANED AND THE ROTATION RELEASE MECHANISM CALIBRATED. THE UNIT WAS FUNCTIONALLY TESTED ACCORDING TO SPECIFICATION WITH APPROVED RESULTS.

  Patient problems: Fall

  MAUDE report 23437406 ↗
• MalfunctionOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(6) 2025: INTEGRUM RECEIVED INFORMATION THAT AXOR II UNIT (B)(4) HAS DETACHED FROM THE PROSTHESIS. THE PATIENT FELL AND INJURED ELBOW AND HAND. (B)(6) 2025: TECHNICAL INVESTIGATION OF UNIT (B)(4) PERFORMED. DURING THE INVESTIGATION THE DEVICE FUNCTIONS WERE TESTED AND COMPONENTS INSPECTED. THE REPORTED ISSUE COULD BE REPLICATED; THE DEVICE COULD BE DETACHED FROM THE ABUTMENT. THE CLAMPS WERE FOUND DIRTY, AND ONCE THE CLAMPS HAD BEEN CLEANED, THE DETACHMENT ISSUE COULD NOT BE REPLICATED. IN ADDITION, SOME WEAR WAS FOUND ON THE CLAMPING NUT. DURING THE SERVICE THE DEVICE WAS THOROUGHLY CLEANED, THE CLAMPING NUT WAS REPLACED, AND THE UNIT WAS FUNCTIONALLY TESTED WITH APPROVED RESULTS. A FEEDBACK REPORT HAS BEEN PROVIDED TO THE CUSTOMER HIGHLIGHTING THE IMPORTANCE OF CLEANING THE AXOR II ACCORDING TO THE IFU, AND THAT THE AXOR II SHOULD NOT BE USED IF A STABLE CONNECTION CANNOT BE ACHIEVED.

  Patient problems: Fall

  MAUDE report 23388805 ↗
• MalfunctionOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON SEPT. 30TH, 2025: INTEGRUM RECEIVED UNIT I7719 WITH A REPORT FORM STATING THAT THE AXOR II HAS DETACHED FROM THE ABUTMENT. NO FALL OR INJURIES REPORTED. DATE OF EVENT UNKNOWN. MANUFACTURING INVESTIGATION PERFORMED, THE UNIT HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. ON OCT. 25TH, 2025: TECHNICAL INVESTIGATION OF UNIT I7719 PERFORMED. DURING THE INVESTIGATION THE DEVICE FUNCTIONS WERE TESTED AND COMPONENTS INSPECTED. THE REPORTED ISSUE COULD NOT BE REPLICATED, THE DEVICE PASSED THE MANUFACTURER'S TESTS RELATED TO GRIPPING FUNCTION. WEAR WAS FOUND ON SOME COMPONENTS NOT IMPACTING THE GRIP. DURING SERVICE, WORN COMPONENTS WERE REPLACED, THE DEVICE WAS THOROUGHLY CLEANED AND FUNCTIONALLY TESTED ACCORDING TO SPECIFICATION WITH APPROVED RESULTS. INTEGRUM HAS PROVIDED A FEEDBACK REPORT HIGHLIGHTING THE IMPORTANCE OF DONNING THE AXOR II ACCORDING TO THE IFU AND THAT THE DEVICE SHALL NOT BE USED IF A STABLE CONNECTION CANNOT BE ACHIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23388793 ↗
• InjuryOct 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  SEPT. 26TH, 2025: INTEGRUM RECEIVED UNIT I9130 WITH A REPORT FORM STATING THAT THE AXOR II HAS DETACHED FROM THE ABUTMENT CAUSING THE PATIENT TO FALL MULTIPLE TIMES, AND THAT THE PATIENT SUSTAINED INJURIES TO THE EYE SOCKET, FINGER AND HIPS AND HAD TO VISIT THE ER. INTEGRUM HAS NOT RECEIVED INFORMATION REGARDING THE SPECIFIC INJURIES, I.E. THE OUTCOME OF THE ER VISIT, HENCE THE CODING SERIOUS INJURY IS A PRESUMTION BASED ON AVAILABLE INFORMATION. MANUFACTURING INVESTIGATION PERFORMED, THE UNIT HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. OCT. 10TH, 2025: TECHNICAL INVESTIGATION OF UNIT I9130 PERFORMED. DURING THE INVESTIGATION THE DEVICE FUNCTIONS WERE TESTED AND COMPONENTS INSPECTED. THE REPORTED ISSUE COULD NOT BE REPLICATED. THE DEVICE PASSED THE MANUFACTURER'S TESTS. THE CLAMPS HAD SOME MINOR MARKS INDICATING THAT THE ABUTMENT MAY NOT HAVE BEEN FULLY INSERTED AT SOME POINT DURING USE, HOWEVER THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE ESTABLISHED. DURING SERVICE, THE CLAMPS WERE REPLACED, THE DEVICE WAS THOROUGHLY CLEANED AND FUNCTIONALLY TESTED ACCORDING TO SPECIFICATION WITH APPROVED RESULTS. INTEGRUM WILL INFORM THE CLINIC ON THE IMPORTANCE OF DONNING THE AXOR II

  Patient problems: Fall

  MAUDE report 23366232 ↗
• MalfunctionAug 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  2025-07-15: INTEGRUM RECEIVED A REPORT FORM STATING THAT THE AXOR II I9531 HAD FALLEN OFF FROM THE ABUTMENT. NO INJURY REPORTED. MANUFACTURING INVESTIGATION PERFORMED, THE UNIT HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. 2025-07-25: TECHNICAL INVESTIGATION PERFORMED. DURING THE INVESTIGATION THE DEVICE FUNCTIONS WERE TESTED AND COMPONENTS INSPECTED. THE REPORTED ISSUE COULD NOT BE REPLICADED. THE CLAMPS SHOWED SIGNS OF MARRING AND IMPROPER DONNING INDICATING THAT THE ABUTMENT MAY NOT HAVE BEEN FULLY INSERTED AT SOME POINT. DURING SERVICE THE CLAMPS WERE REPLACED. THE DEVICE WAS THOROUGHLY CLEANED AND FUNCTIONALLY TESTED ACCORDING TO SPECIFICATION WITH APPROVED RESULTS. INTEGRUM HAS INFORMED THE CLINIC ON THE IMPORTANCE OF DONNING THE AXOR II ACCORDING TO THE IFU TO ENSURE A STABLE CONNECTION AND PREVENT DAMAGE OR WEAR TO THE CLAMPS. AS STATED IN THE IFU, THE DEVICE SHALL NOT BE USED IF A STABLE CONNECTION CANNOT BE ACHIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801966 ↗
• MalfunctionAug 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  2025-08-11: INTEGRUM HAS BEEN INFORMED THAT AXOR II UNIT (B)(6) HAD FALLEN OFF FROM THE ABUTMENT. NO INJURY REPORTED. THE EXACT DATE IS UNKNOWN. THE UNIT HAS NOT BEEN RECEIVED AT INTEGRUM. TECHNICAL INVESTIGATION HAS NOT YET BEEN PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791957 ↗
• MalfunctionAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  2025-07-15: INTEGRUM RECEIVED INFORMATION ABOUT AXOR II UNIT (B)(6) STATING PROBLEM WITH ROTATION RELESE. THE PATIENT FELL AND HIT HIS HEAD ON PAVEMENT. MANUFACTURING INVESTIGATION PERFORMED, BATCH DOCUMENTATION REVIEWED. NO DEVIATIONS FOUND, THE DEVICE HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. TECHNICAL INVESTIGATION OF UNIT (B)(6) PERFORMED. DURING THE INVESTIGATION THE DEVICE FUNCTIONS WERE TESTED AND COMPONENTS INSPECTED. THE REPORTED ISSUE COULD NOT BE REPLICATED; THE ROTATION RELEASE VALUE WAS WITHIN THE SPECIFICATION. THE DEVICE SHOWED SIGNS OF POOR MAINTENANCE. THE UNIT HAS NOT BEEN SENT TO INTEGRUM FOR ANNUAL SERVICE ACCORDING TO INSTRUCTIONS IN THE IFU. THE CLAMPS WERE DAMAGED AND SHOWED SIGNS OF IMPROPER DONNING. DURING THE SERVICE THE DEVICE WAS THOROUGHLY CLEANED, THE CLAMPS REPLACED, AND THE ROTATIONAL RELEASE CALIBRATED. FINALLY, IT WAS FUNCTIONALLY TESTED WITH APPROVED RESULTS. INTEGRUM HAS INFORMED THE CLINIC ON THE IMPORTANCE OF DONNING THE AXOR II ACCORDING TO THE IFU TO ENSURE A STABLE CONNECTION AND PREVENT DAMAGE OR WEAR TO THE CLAMPS. AS STATED IN THE IFU, THE DEVICE SHALL NOT BE USED IF A STABLE CONNECTION CANNOT BE ACHIEVED.

  Patient problems: Fall

  MAUDE report 22769818 ↗
• MalfunctionJun 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  2025-05-28: INTEGRUM RECEIVED A REPORT FORM STATING THAT THE AXOR II (B)(6) HAD FALLEN OFF FROM THE ABUTMENT. NO INJURY REPORTED. MANUFACTURING INVESTIGATION PERFORMED, THE UNIT HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. 2025-06-05: TECHNICAL INVESTIGATION OF UNIT (B)(6) PERFORMED. DURING THE INVESTIGATION THE DEVICE FUNCTIONS WERE TESTED AND COMPONENTS INSPECTED. THE REPORTED ISSUE COULD NOT BE REPLICADED. THE DEVICE PASSED THE MANUFACTURER'S TESTS. THE DEVICE WAS THOROUGHLY CLEANED. FINALLY, IT WAS FUNCTIONALLY TESTED WITH APPROVED RESULTS. INTEGRUM HAS INFORMED THE CLINIC ON THE IMPORTANCE OF DONNING THE AXOR II ACCORDING TO THE IFU TO ENSURE A STABLE CONNECTION AND PREVENT DAMAGE OR WEAR TO THE CLAMPS. AS STATED IN THE IFU, THE DEVICE SHALL NOT BE USED IF A STABLE CONNECTION CANNOT BE ACHIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201391 ↗
• MalfunctionMay 26, 2025Off-Label Use; Off-Label Use

  2024-09-10 INTEGRUM RECEIVED INFORMATION ABOUT AXOR II UNIT I6997 STATING PROBLEM WITH ROTATION RELEASE AND THAT THE PATIENT HAD FALLEN. AN "INITIAL" MIR REPORT WAS SENT TO SWEDISH MPA 2024-09-24. DURING THE TECHNICAL INVESTIGATION THE REPORTED ISSUE COULD NOT BE REPLICATED. THE ROTATION SAFETY RELEASE MECHANISM WAS NOT TOO LOW. ADDITIONAL INFORMATION WAS RECEIVED DURING THE INVESTIGATION, THE FALL RESULTED IN A DOCTOR´S VISIT AND NOT HOSPITALIZATION. A FINAL (NON-REPORTABLE) REPORT REF. (B)(4) WAS SENT TO SWEDISH MPA 2024-10-11. 2025-01-17 INTEGRUM RECEIVED INFORMATION ABOUT AXOR II UNIT I6997 STATING PROBLEM WITH ROTATION RELEASE AND THAT THE PATIENT HAD FALLEN. NO HEALTH CONSEQUENCES OR PATIENT INJURY REPORTED. THE EXACT DATE OF EVENT IS UNKNOWN. THE UNIT HAS NOT BEEN RECEIVED AT INTEGRUM HENCE, TECHNICAL INVESTIGATION HAS NOT YET BEEN PERFORMED. THE AXOR II UNIT I6997 IS IN CUSTODY AT VGR ACCORDING TO THE (B)(4) REPORT, 2025-03-14. INTEGRUM HAS HAD SEVERAL MEETINGS AND ARE IN CLOSE CONTACT WITH (B)(6). THIS EVENT WAS CONCLUDED NOT REPORTABLE BY INTEGRUM (INTERNAL CASE ID #1870). DURING EMAIL CONVERSATION BETWEEN THE PATIENT AND THE CLINIC, INFORMATION WAS RECEIVED THAT THE PATI

  Patient problems: Fall

  MAUDE report 22084130 ↗
• MalfunctionMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  2025-04-17: INTEGRUM HAS BEEN INFORMED THAT AXOR II UNIT (B)(6) HAS FALLEN OFF FROM THE ABUTMENT. THE PATIENT FELL. NO INJURIES REPORTED. THE EXACT DATE OF EVENT IS UNKNOWN. 2025-04-25: MANUFACTURING INVESTIGATION PERFORMED, BATCH DOCUMENTATION REVIEWED. NO DEVIATIONS FOUND, THE DEVICE HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. 2025-04-30: TECHNICAL INVESTIGATION PERFORMED. DURING THE INVESTIGATION THE DEVICE FUNCTIONS WERE TESTED AND COMPONENTS INSPECTED. THE REPORTED ISSUE COULD BE REPLICATED. THE CLAMPS HAD MARKS AND WERE DAMAGED INDICATING THAT THE ABUTMENT MAY NOT HAVE BEEN FULLY INSERTED AT SOME POINT. DURING SERVICE THE CLAMPS WERE REPLACED. THE DEVICE WAS THOROUGHLY CLEANED AND FUNCTIONALLY TESTED ACCORDING TO SPECIFICATION WITH APPROVED RESULTS. INTEGRUM HAS INFORMED THE CLINIC ON THE IMPORTANCE OF DONNING THE AXOR II ACCORDING TO THE IFU TO ENSURE A STABLE CONNECTION AND PREVENT DAMAGE OR WEAR TO THE CLAMPS. AS STATED IN THE IFU, THE DEVICE SHALL NOT BE USED IF A STABLE CONNECTION CANNOT BE ACHIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22024544 ↗
• MalfunctionMay 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  2025-04-16: INTEGRUM HAS BEEN INFORMED THAT AXOR II UNIT I9774 HAS FALLEN OFF FROM THE ABUTMENT. NO HEALTH CONSEQUENCES OR INJURY REPORTED. THE EXACT DATE OF EVENT IS UNKNOWN. 2025-04-24: MANUFACTURING INVESTIGATION PERFORMED, BATCH DOCUMENTATION REVIEWED. NO DEVIATIONS FOUND, THE DEVICE HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. 2025-04-28. TECHNICAL INVESTIGATION OF UNIT I9774 PERFORMED. DURING THE INVESTIGATION THE DEVICE FUNCTIONS WERE TESTED AND COMPONENTS INSPECTED. THE REPORTED ISSUE COULD NOT BE REPLICATED. THE DEVICE SHOWED SIGNS OF WEAR AND LACK OF MAINTENANCE. DURING THE SERVICE THE DEVICE WAS THOROUGHLY CLEANED AND DAMAGED COMPONENTS WERE REPLACED. FINALLY, THE DEVICE WAS FUNCTIONALLY TESTED WITH APPROVED RESULTS. INTEGRUM HAS INFORMED THE CLINIC ON THE IMPORTANCE OF DONNING THE AXOR II ACCORDING TO THE IFU TO ENSURE A STABLE CONNECTION AND PREVENT DAMAGE OR WEAR TO THE CLAMPS. IT IS IMPORTANT TO MOVE THE LEG/TAP THE FOOT ON THE FLOOR, TIGHTEN FURTHER AND CHECK THE ATTACHMENT. AS STATED IN THE IFU, THE DEVICE SHALL NOT BE USED IF A STABLE CONNECTION CANNOT BE ACHIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993888 ↗
• MalfunctionMay 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025: INTEGRUM RECEIVED A REPORT FORM STATING THAT THE AXOR II I9815 HAD FALLEN OFF FROM THE ABUTMENT. THE PATIENT FELL WHICH CAUSED AN INTERNAL BLEEDING IN THE STUMP AND HOSPITALIZATION. THE EXACT DATE OF THE INCIDENT IS UNKNOWN. MANUFACTURING INVESTIGATION PERFORMED, THE UNIT HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. THE UNIT NOT YET RECEIVED; HENCE NO TECHNICAL INVESTIGATION HAS BEEN PERFORMED YET.

  Patient problems: Fall

  MAUDE report 21983920 ↗
• MalfunctionMar 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  2025-03-05: INTEGRUM HAS BEEN INFORMED THAT AXOR II UNIT (B)(6) HAS FALLEN OFF FROM THE ABUTMENT. MANUFACTURING INVESTIGATION PERFORMED; BATCH DOCUMENTATION REVIEWED. NO DEVIATIONS FOUND; THE DEVICE HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. 2025-03-18. TECHNICAL INVESTIGATION OF UNIT (B)(6) PERFORMED. DURING THE INVESTIGATION THE DEVICE FUNCTIONS WERE TESTED AND COMPONENTS INSPECTED. THE REPORTED ISSUE COULD NOT BE REPLICATED. THE CLAMPS WERE SHOWING SIGNS OF WEAR INDICATING THAT THE ABUTMENT MAY HAVE NOT BEEN FULLY INSERTED AT SOME POINT. DURING THE SERVICE THE DEVICE WAS THOROUGHLY CLEANED AND DAMAGED COMPONENTS WERE REPLACED. FINALLY, THE DEVICE WAS FUNCTIONALLY TESTED WITH APPROVED RESULTS. INTEGRUM HAS INFORMED THE CLINIC ON THE IMPORTANCE OF DONNING THE AXOR II ACCORDING TO THE IFU TO ENSURE A STABLE CONNECTION AND PREVENT DAMAGE OR WEAR TO THE CLAMPS. AS STATED IN THE IFU, THE DEVICE SHALL NOT BE USED IF A STABLE CONNECTION CANNOT BE ACHIEVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699166 ↗
• MalfunctionMar 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 2025-02-27: INTEGRUM HAS BEEN INFORMED THAT AXOR II UNIT (B)(6) HAS FALLEN OFF FROM THE ABUTMENT. NO FURTHER INFORMATION IS AVAILABLE YET AND THE UNIT HAS NOT YET BEEN RECEIVED AT INTEGRUM. MANUFACTURING INVESTIGATION PERFORMED, BATCH DOCUMENTATION REVIEWED. NO DEVIATIONS FOUND, THE DEVICE HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. TECHNICAL INVESTIGATION HAS NOT YET BEEN PERFORMED. ON 2025-03-26: VIDEO OF DONNING/DOFFING AND PHOTOS OF THE ABUTMENT RECEIVED FROM THE CLINIC. HOWEVER, THE RECEIVED INFORMATION IS NOT EFFICENT FOR PERFORMING TECHNICAL INVESTIGATION. INTEGRUM HAS BEEN IN CONTACT WITH THE CLINIC SEVERAL TIMES BUT NOT YET RECEIVED THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676780 ↗
• MalfunctionMar 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(6) 2025: INTEGRUM HAS BEEN INFORMED THAT AXOR II UNIT I9106 HAS FALLEN OFF FROM THE ABUTMENT (B)(6) 2024 - (B)(6) 2025. NO HEALTH CONSEQUENCES OR PATIENT INJURY REPORTED. MANUFACTURING INVESTIGATION PERFORMED; BATCH DOCUMENTATION REVIEWED. NO DEVIATIONS FOUND; THE DEVICE HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. (B)(6) 2025: TECHNICAL INVESTIGATION OF UNIT I9106 PERFORMED. DURING THE INVESTIGATION THE DEVICE FUNCTIONS WERE TESTED AND COMPONENTS INSPECTED. THE REPORTED ISSUE COULD NOT BE REPLICATED. THE DEVICE SHOWED SIGNS OF POOR MAINTENANCE. THE UNIT HAS NOT BEEN SENT TO INTEGRUM FOR ANNUAL SERVICE ACCORDING TO INSTRUCTIONS IN THE IFU. THE CLAMPS WERE DAMAGED AND SHOWED SIGNS OF IMPROPER DONNING. DURING THE SERVICE THE DEVICE WAS THOROUGHLY CLEANED. DAMAGED AND WORN COMPONENTS WERE REPLACED. FINALLY, THE DEVICE WAS FUNCTIONALLY TESTED WITH APPROVED RESULTS. INTEGRUM HAS INFORMED THE CLINIC ON THE IMPORTANCE OF DONNING THE AXOR II ACCORDING TO THE IFU TO ENSURE A STABLE CONNECTION AND PREVENT DAMAGE OR WEAR TO THE CLAMPS. AS STATED IN THE IFU, THE DEVICE SHALL NOT BE USED IF A STABLE CONNECTION CANNOT BE ACHIEVED. INTEGRUM HAS ALSO CONTACTED THE CLINIC TO HIGHLIGHT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641543 ↗
• MalfunctionFeb 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  2025-01-27: INTEGRUM RECEIVED UNIT (B)(6) TOGETHER WITH A REPORT FORM STATING THAT THE AXOR II HAS FALLEN OFF THE ABUTMENT DURING USE. NO INJURIES REPORTED. 2025-01-28: MANUFACTURING INVESTIGATION PERFORMED; BATCH DOCUMENTATION REVIEWED. NO DEVIATIONS FOUND; THE DEVICE HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. 2025-01-29: TECHNICAL INVESTIGATION PERFORMED OF UNIT (B)(6). DURING INVESTIGATION THE REPORTED ISSUE COULD BE REPLICATED. HOWEVER, THE CLAMPS WERE DAMAGED INDICATING THAT THE ABUTMENT HAS NOT BEEN INSERTED ALL THE WAY INTO THE AXOR II DURING USE. IN ADDITIONAL, SEVERAL COMPONENTS WERE DAMANGED AND THE TOP SPRING WAS MOUNTED INCORRECTLY. 2025-01-30: DURING SERVICE THE UNIT WAS THROUGHLY CLEANED AND THE DAMAGED CLAMPS AND COMPONENTS WERE REPLACED. THE UNIT WAS FUNCTIONALLY TESTED ACCORDING TO SPECIFICATION WITH APPROVED RESULTS. A FEEDBACK REPORT IS SENT TO THE CUSTOMER HIGHLIGHTING THE IMPORTANCE OF DONNING THE AXOR II ACCORDING TO THE IFU TO ENSURE A STABLE CONNECTION AND PREVENT DAMAGE OR WEAR TO THE CLAMPS. IT IS IMPORTANT TO MOVE THE LEG/TAP THE FOOT ON THE FLOOR, TIGHTEN FURTHER AND CHECK THE ATTACHMENT. AS STATED IN THE IFU, THE DEVICE SHALL NOT BE USED IF A STA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459497 ↗
• MalfunctionFeb 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  2025-02-11: INTEGRUM HAS BEEN INFORMED THAT AXOR II UNIT (B)(6) HAS FALLEN OFF FROM THE ABUTMENT. NO INJURY REPORTED. MANUFACTURING INVESTIGATION PERFORMED; BATCH DOCUMENTATION REVIEWED. NO DEVIATIONS FOUND; THE DEVICE HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. TECHNICAL INVESTIGATION HAS NOT YET BEEN PERFORMED. 2025-03-12: TECHNICAL INVESTIGATION OF UNIT (B)(6) PERFORMED. DURING THE INVESTIGATION THE DEVICE FUNCTIONS WERE TESTED AND COMPONENTS INSPECTED. THE REPORTED ISSUE COULD NOT BE REPLICATED. THE DEVICE WAS DIRTY AND SHOWED SIGNE'S OF POOR CARE/MAINTENANCE. THE CLAMPS HAD MARKS AND WERE DAMAGED INDICATING THAT THE ABUTMENT MAY HAVE NOT BEEN FULLY INSERTED AT SOME POINT. DURING SERVICE THE CLAMPS WERE REPLACED. THE DEVICE WAS THOROUGHLY CLEANED AND FUNCTIONALLY TESTED ACCORDING TO SPECIFICATION WITH APPROVED RESULTS. A FEEDBACK REPORT SENT TO THE CUSTOMER HIGHLIGHT THE IMPORTANCE OF DONNING THE AXOR II ACCORDING TO THE IFU TO ENSURE A STABLE CONNECTION AND PREVENT DAMAGE OR WEAR TO THE CLAMPS. THE IMPORTANCE TO MOVE THE LEG/TAP THE FOOT ON THE FLOOR, TIGHTEN FURTHER AND CHECK THE ATTACHMENT. AS STATED IN THE IFU, THE DEVICE SHALL NOT BE USED IF A STABLE CONNECTION CANNO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457682 ↗
• MalfunctionFeb 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(6) 2025: INTEGRUM HAS BEEN INFORMED THAT AXOR II UNIT I9097 HAS FALLEN OFF FROM THE ABUTMENT. NO HEALTH CONSEQUENCES OR PATIENT INJURY REPORTED. (B)(6) 2025: MANUFACTURING INVESTIGATION PERFORMED; BATCH DOCUMENTATION REVIEWED. NO DEVIATIONS FOUND; THE DEVICE HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. (B)(6) 2025: TECHNICAL INVESTIGATION OF UNIT I9097 PERFORMED. DURING THE INVESTIGATION THE FUNCTIONS WERE TESTED AND COMPONENTS INSPECTED. THE REPORTED ISSUE COULD NOT BE REPLICATED. THE CLAMPS SHOWED SIGNS OF WEAR INDICATING THAT THE ABUTMENT MAY NOT HAVE BEEN FULLY INSERTED AT SOME POINT. DURING SERVICE THE CLAMPS WERE REPLACED. THE DEVICE WAS THOROUGHLY CLEANED AND FUNCTIONALLY TESTED ACCORDING TO SPECIFICATION WITH APPROVED RESULTS. A FEEDBACK REPORT HAS BEEN PROVIDED TO THE CUSTOMER HIGHLIGHTING THE IMPORTANCE OF ATTACHING THE AXOR II ACCORDING TO THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21410467 ↗
• MalfunctionFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(6) 2025: INTEGRUM HAS BEEN INFORMED THAT AXOR II UNIT(B)(4). HAS FALLEN OFF FROM THE ABUTMENT. NO HEALTH CONSEQUENCES OR PATIENT INJURY REPORTED. MANUFACTURING INVESTIGATION PERFORMED, BATCH DOCUMENTATION REVIEWED. NO DEVIATIONS FOUND, THE DEVICE HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. (B)(6) 2025: TECHNICAL INVESTIGATION OF UNIT (B)(4).PERFORMED. DURING THE INVESTIGATION THE FUNCTIONS WERE TESTED AND COMPONENTS INSPECTED. THE REPORTED ISSUE COULD NOT BE REPLICADED. THE CLAMPS SHOWED MARKS WHICH INDICATES THAT THE ABUTMENT MAY NOT HAVE BEEN FULLY INSERTED AT SOME POINT. IN ADDITION, SEVERAL COMPONENTS WERE DAMAGED AND INCREDIBLY DIRTY DUE TO POOR MAINTENANCE. DURING SERVICE, WORN COMPONENTS WERE REPLACED. THE DEVICE WAS THOROUGHLY CLEANED AND FUNCTIONALLY TESTED ACCORDING TO SPECIFICATION WITH APPROVED RESULTS. (B)(6) 2025: A FEEDBACK REPORT SENT TO THE CUSTOMER HIGHLIGHT THE IMPORTANCE OF DONNING THE AXOR II ACCORDING TO THE IFU TO ENSURE A STABLE CONNECTION AND PREVENT DAMAGE OR WEAR TO THE CLAMPS. THE IMPORTANCE TO MOVE THE LEG/TAP THE FOOT ON THE FLOOR, TIGHTEN FURTHER AND CHECK THE ATTACHMENT. AS STATED IN THE IFU, THE DEVICE SHALL NOT BE USED IF A STABLE CONNECT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294177 ↗