OPRA Implant System 1820Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07340152100726), received between Jun 3, 2020 and Sep 22, 2023 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2023Fracture; Fracture

  ABUTMENT AND ABUTMENT SCREW REPLACEMENT SURGERY DUE TO FRACTURED ABUTMENT.BLACK SECRETION AND PAIN WHEN LOADING WERE REPORTED AS CLINICAL SIGNS.COMPONENT REPLACEMENT SURGERY TOOK PLACE ON (B)(6) 2023.

  Patient problems: Fluid Discharge; Implant Pain

  MAUDE report 17798041 ↗
• InjuryMay 10, 2022Mechanical Problem; Unintended Movement; Mechanical Problem; Unintended Movement

  ABUTMENT AND ABUTMENT SCREW REPLACEMENT SURGERY FOR A PATIENT DUE TO PRESS FIT WEAR THAT RESULTED IN BLACK SECRETION OUT OF THE ABUTMENT EXIT SITE AND LOOSENING WITH NO SOFT TISSUE COMPLICATION. THE PATIENT HAD THE COMPONENTS REPLACED AS A DAY SURGERY PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 14344606 ↗
• InjuryMar 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  REPLACEMENT SURGERY FOR THE PATIENT WITH THE BROKEN ABUTMENT SCREW. THE PATIENT WAS WALKING WHEN THE ABUTMENT SCREW FRACTURED AND THE ABUTMENT FELL OUT. THE PATIENT DID NOT FALL. THE PATIENT HAD THE COMPONENTS REPLACED AS A DAY SURGERY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13692378 ↗
• MalfunctionNov 16, 2021Off-Label Use; Off-Label Use

  2021-10-19: QA AT INTEGRUM RECEIVED AN E-MAIL ABOUT AN ABUTMENT REPLACEMENT SURGERY FOR A TRANSFEMORAL PATIENT. THE REPLACEMENT IS DONE DUE TO SUSPECTED WEAR ON THE ABUTMENT HEAD CAUSING PROBLEMS WITH CONNECTING THE AXOR II. AS PER INFORMATION, THIS IS A BILATERAL AMPUTEE PATIENT, AND THE REPLACEMENT CONCERNS THE RIGHT AMPUTATION SIDE. REPORT FORM AS WELL AS PRODUCT IN QUESTION HAS BEEN REQUESTED ONCE THE SURGERY IS PERFORMED. 2021-10-27: REPORT FORM SPECIFYING DETAILS BEHIND THE INCIDENT HAS BEEN PROVIDED. AS REPORTED BY THE TREATING SURGEON, THIS IS A HIGHLY ACTIVE PATIENT, RESULTING IN METAL EROSION/WEAR OF THE ABUTMENT HEAD, WITH VISIBLE GROOVES ON THE SQUARE HEAD PRESENT. THE AXOR II IS FALLING OFF, DUE TO AMOUNT OF WEAR ON THE ABUTMENT HEAD AND THE AXOR II DEVICE CANNOT GRIP THE ABUTMENT. ACCORDING TO THE INFORMATION FROM THE SALES REP AT INTEGRUM, THE SURGERY WENT ACCORDING TO PLAN. IT WAS EASY TO REMOVE THE ABUTMENT WITH THE EXTRACTION KIT. THE NEW ABUTMENT AND ABUTMENT SCREW WERE PLACED AND THE PATIENT IS BACK ON THE SYSTEM. 2021-11-12: THE REPLACED PRODUCT HAS NOT BEEN RECEIVED AT INTEGRUM SO THE FURTHER INVESTIGATION CANNOT BE PERFORMED. IT HAS MOST LIKELY BEEN DISCARDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821034 ↗
• InjuryJul 14, 2021Microbial Contamination of Device; Appropriate Device Problem Term/Code Not Available

  2021-06-29: QA HAS BECOME AWARE ABOUT AN UNREPORTED EVENT REGARDING DEEP INFECTION. THE SALES REP AT INTEGRUM INC. HAS INFORMED THAT THE PATIENT HAD AN INFECTION AFTER THE REPLACEMENT OF ABUTMENT (SN (B)(4), LOT 9202) AND ABUTMENT SCREW. THE ABUTMENT/ABUTMENT SCREW WERE REMOVED AGAIN AND ANTIBIOTIC BEADS WERE INSERTED. THE NEW ABUTMENT AND ABUTMENT SCREW WERE INSTALLED ON (B)(6) 2020, WHEN THE INFECTION WAS HEALED. IMPLANTS USED IN THE FINAL ATTEMPT AT (B)(6) HOSPITAL ARE REF 1999 ABUTMENT SCREW LOT 9312, AND 1820 ABUTMENT 12X78 SERIAL NUMBER (B)(4) LOT# 9821. THIS IS A FEMUR BILATERAL + LEFT TRANSHUMERAL PATIENT. THE REPLACED ABUTMENT AND AB. SCREW WERE FROM THE LEFT FEMUR SIDE.

  Patient problems: Osteomyelitis

  MAUDE report 12165594 ↗
• InjuryJul 14, 2021Unclear Information; Unclear Information

  2021-06-23: QA AT INTEGRUM HAS BECOME AWARE ABOUT A PATIENT SCHEDULED FOR A SURGERY DUE TO ABUTMENT FRACTURE WITH BENT ABUTMENT SCREW. THE PROBABLE CAUSE IS TRAUMA WHICH HAS BEEN COMMUNICATED WITH SALES REP AT INT INC., BUT NO DETAILS HAD BEEN SPECIFIED. AS PER INFO PROVIDED VIA REPORT FORM, THE PATIENT FELL WHILE WALKING UPSTAIRS WITH HIS PROSTHETIC FOOT STEPPED ON A CHIP STICKING OUT FROM THE GROUND. THE PATIENT FELL ON HIS ABUTMENT WHEN FAIL SAFE ACTIVATED. INTEGRUM AB IS FOLLOWING UP VIA SALES REP TO GET MORE INFORMATION NEEDED TO UNDERSTAND THE CASE. 2021-07-07: THE REPLACED PRODUCT WAS SENT BACK TO IAB ON (B)(6), YET NOT RECEIVED YET. TECHNICAL ANALYSIS TO BE PERFORMED ONCE THE PART IS DELIVERED. MANUFACTURING BATCH HAS BEEN REVIEWED AND NO DEVIATION RELATED TO THE PRODUCT WAS FOUND. 2021-09-01: PARTS HAVE BEEN RECEIVED AT INTEGRUM. VISUAL INSPECTION OF THE RETRIEVED COMPONENTS INDICATE A SUDDEN FRACTURE. THE ABUTMENT SCREW IS BENT AND STUCK INSIDE THE DISTAL PART OF THE ABUTMENT WHICH SUGGEST FURTHER SUGGEST THAT THE SYSTEM HAS BEEN SUBJECTED TO HIGH LOADS, FRACTURING THE ABUTMENT AND BENDING THE ABUTMENT SCREW DURING THE FALL. THE CAUSE OF THE FAILURE IS KNOWN, AND THERE IS

  Patient problems: Fall

  MAUDE report 12165590 ↗
• InjuryJul 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 2021-07-05: QA AT INTEGRUM WAS NOTIFIED ABOUT A PATIENT HAVING PROBLEMS WITH HIS AXOR FALLING OFF. NO REPORT FORM HAVE BEEN PROVIDED. MANUFACTURING BATCH HAS BEEN REVIEWED AND NO DEVIATION RELATED TO THE PRODUCT WAS FOUND. NO COMPLICATION ON THE ABUTMENT ITSELF COULD BE DETECTED, THE ABUTMENT WAS STABLE, NO BLACK SECRETION HAS BEEN REPORTED. THE AXOR WAS SERVICED YET IT DIDN'T SOLVE THE ISSUE. THE FINAL ATTEMPT WAS TO REPLACE THE ABUTMENT. THE REPLACEMENT SURGERY WAS PERFORMED ON (B)(6) 2021. IT WENT ACCORDING TO PLAN AND THE PATIENT WAS FITTED WITH BIGGER SIZE ABUTMENT TO SECURE THE PRESS-FIT. THE REPLACED ABUTMENT WAS SENT BACK TO INTEGRUM FOR TECHNICAL INSPECTION. NO REPORT FORM WAS PROVIDED THOUGH. ON 2021-07-07: VISUAL INSPECTION CONFIRMS WEAR ON THE ABUTMENT HEAD. THE PRODUCT WAS IMPLANTED MORE THAN 3 YEARS AGO (S2 SURGERY ON (B)(6) 2018).

  Patient problems: Insufficient Information

  MAUDE report 12154105 ↗
• InjuryJun 3, 2020Off-Label Use; Off-Label Use

  FRACTURED ABUTMENT SCREW. IT WAS THE PATIENT'S LEFT LEG AND THE ABUTMENT SCREW BROKE WHEN HE TIGHTENED IT HIMSELF. HE SAID HE DID USE A TORQUE LIMITING DRIVER BUT HE DID THIS A FEW TIMES SINCE OVER THE PAST YEAR. THIS IS NOT NORMAL PRACTICE AT (B)(6). THE ROOT CAUSE SEEMS MOST LIKELY TO BE THE RETIGHTENING.

  Patient problems: No Code Available

  MAUDE report 10114121 ↗