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OPRA Implant System IBC0010Recalls & reported problems

Integrum AB · Fixture 17x80 · Class 3 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07340152100429), received between Oct 16, 2020 and Jul 14, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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

Device problems

  • Loss of Osseointegration2
  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Osteomyelitis2
  • Implant Pain1
  • Inadequate Osseointegration1
  • Osteolysis1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 14, 2021Loss of Osseointegration; Loss of Osseointegration

    2021-07-07: QA HAS BEEN NOTIFIED IN JUNE ABOUT A POTENTIAL FIXTURE REMOVAL OF ONE PATIENT DUE TO OSTEOMYELITIS PLANNED IN CHILE. THE SURGERY DATE WAS SET (B)(6) 2021. NO INFORMATION ON SN/LOT OF THE FIXTURE IS AVAILABLE AND HAS NOT BEEN PROVIDED BY THE TREATING TEAM. THE PATIENT WAS IMPLANTED 2011 AND THE FIXTURE REMOVAL SURGERY DOES NOT CONCERN THE PLATFORM G INTRODUCED ON THE MARKET IN 2017. SALES TEAM AT (B)(6) HAS PROVIDED THE TREATING TEAM WITH THE SURGICAL MANUAL FOR ABUTMENT EXTRACTION AN FIXTURE REMOVAL (B)(6) , WHILE THE INSTRUMENTS NEEDED FOR THE REMOVAL SURGERY ON (B)(6) 2021. MORE INFORMATION IS EXPECTED AFTER SURGERY IS PERFORMED ON (B)(6). NO INFORMATION PROVIDED YET.

    Patient problems: Osteomyelitis

    MAUDE report 12165597 ↗
  • InjuryOct 16, 2020Loss of Osseointegration; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

    ON (B)(6) 2020: IT HAS BEEN REPORTED TO THE INTEGRUM (B)(6) THAT A FIXTURE REMOVAL SURGERY HAS BEEN PERFORMED (B)(6) . THE PATIENT HAS HAD THE FIXTURE FOR MORE THAN 8 YEARS. PATIENT HAS HAD HISTORY OF BONE LOSS AROUND THE IMPLANT. NO REPORT FORM OR INFORMATION RECEIVED REGARDING THE INCIDENT OR THE REASON BEHIND THE FIXTURE REMOVAL. NO MORE INFORMATION EXCEPT FOR THE DATE OF THE SURGERY WHEN THE FIXTURE REMOVAL WAS PERFORMED. THE TREATING DOCTOR HAS BEEN REQUESTED ON (B)(6) 2020 TO SEND THE REPORT FORM FILLED IN. IMPLANT HAS NOT BEEN DELIVERED YET. 2020-10-16: ABUTMENT HAS BEEN RETURNED TO INTEGRUM. IT HAS BEEN REPORTED TO THE INTEGRUM THAT A FIXTURE REMOVAL SURGERY HAS BEEN PERFORMED. THE PATIENT HAS HAD THE FIXTURE FOR MORE THAN 8 YEARS. PATIENT HAS HAD HISTORY OF BONE LOSS AROUND THE IMPLANT, OSTEOMYELITIS. NO REPORT FORM OR INFORMATION RECEIVED REGARDING THE INCIDENT OR THE REASON BEHIND THE FIXTURE REMOVAL. DURING THE SURGERY (B)(6) THE FIXTURE WAS REMOVED AND IT WAS REPORTED THAT THE BONE WAS HARD AND THE FIXTURE TUFF TO REMOVE WITCH INDICATE THAT THE REMAINING PART WAS WELL OSSEOINTEGRATED. QA HAS REQUESTED MORE INFORMATION REGARDING THE FIXTURE REMOVAL. 2020-10-24: THE SALE

    Patient problems: Implant Pain; Inadequate Osseointegration; Osteolysis; Osteomyelitis

    MAUDE report 10693138 ↗

Other Transfemoral Percutaneous Prosthetic devices

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Sources and updates

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