iFuse Implant System 7035M-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00851085007305), received between Sep 26, 2018 and Jan 24, 2022 — classified as 16 injuries.

The most frequently reported specific device problem is “Malposition of Device” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2022Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT IS OSTEOPOROTIC. THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER COMPLAINED OF A RECURRENCE OF SI-JOINT PAIN SYMPTOMS. THE SURGEON THOUGHT THAT THE INFERIOR POSITIONED IMPLANT MAY HAVE BEEN LOOSE. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT AND ADDED A NEW IMPLANT OF A DIFFERENT TYPE IN A MORE ANTERIOR POSITION FROM THE INITIAL IMPLANT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS UNKNOWN.

  Patient problems: Arthralgia

  MAUDE report 13335097 ↗
• InjuryNov 29, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF BUTTOCK PAIN POST OP AND PAIN RADIATING DOWN LEG. THE INFERIOR IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE INFERIOR-POSITIONED IMPLANT. NO BONE GRAFT OR ADDITIONAL HARDWARE WAS ADDED. NONE OF THE OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 12887921 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER COMPLAINED OF CONTINUED SI JOINT PAIN. THE SURGEON PERFORMED A DIAGNOSTIC INJECTION DIRECTLY OVER THE INFERIOR POSITIONED IMPLANT WHICH GAVE THE PATIENT PAIN RELIEF. THE SURGEON DID NOT DETERMINE THAT THE IMPLANT WAS LOOSE OR MALPOSITIONED BUT DECIDED TO REMOVE THE IMPLANT ANYWAY. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE RIGHT SIDE INFERIOR POSITIONED IMPLANT. THE IMPLANT WAS SOLIDLY FIXED IN BONE AND WAS DIFFICULT TO REMOVE. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 12595429 ↗
• InjuryJul 14, 2021Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR APPROXIMATELY FOUR MONTHS BEFORE COMPLAINING OF A RECURRENCE OF SI JOINT PAIN SYMPTOMS. THE PATIENT COMPLAINED OF LOCAL PAIN AT THE CAUDAL IMPLANT SITE. THE SURGEON THOUGHT THE CAUDAL IMPLANT WAS SLIGHTLY LOOSE BUT DID NOT SEE ANY HALOS OR LUCENCY AROUND THE CAUDAL IMPLANT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CAUDAL POSITIONED IMPLANT AND FILLED THE EXPLANT VOID WITH BONE GRAFT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS UNKNOWN.

  Patient problems: Arthralgia

  MAUDE report 12166641 ↗
• InjuryMay 11, 2021Inadequacy of Device Shape and/or Size; Loss of Osseointegration; Inadequacy of Device Shape and/or Size; Loss of Osseointegration

  THE PATIENT HAD LEFT SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR SIX MONTHS BEFORE COMPLAINING OF A RECURRENCE OF SI-JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED LOOSENING OF THE MIDDLE POSITIONED IMPLANT WHICH MAY HAVE BEEN TOO SHORT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE MIDDLE POSITIONED IMPLANT AND REPLACED IT WITH A LONGER IMPLANT OF THE SAME TYPE. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 11809689 ↗
• InjuryApr 6, 2021Malposition of Device; Malposition of Device

  IN (B)(6) 2019, THE PATIENT HAD LEFT SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR A FEW WEEKS BEFORE FOLLOWING THE INITIAL PROCEDURE BUT LATER REPORTED A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS NOT POSITIONED FULLY ACROSS THE SI JOINT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE ADVANCED THE INFERIOR POSITIONED IMPLANT FURTHER ACROSS THE SI JOINT AND ADDED BONE GRAFT TO THE SI JOINT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. NO NEW HARDWARE WAS ADDED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 11625560 ↗
• InjuryMar 29, 2021Malposition of Device; Malposition of Device

  IN (B)(6) 2020 THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT INITIALLY DID WELL AFTER THE PROCEDURE BUT LATER REPORTED LEFT SIDE RADICULAR PAIN. THE SURGEON DETERMINED THAT THE CAUDAL POSITIONED IMPLANT WAS MALPOSITIONED AND IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CAUDAL POSITIONED IMPLANT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. NO ADDITIONAL HARDWARE WAS ADDED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 11583056 ↗
• InjuryMar 11, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOLLOWING THE INITIAL PROCEDURE, BUT LATER REPORTED A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS MALPOSITIONED TOO POSTERIORLY. IN (B)(6) 2021, THE SURGEON REMOVED THE INFERIOR POSITIONED IMPLANT. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 11467352 ↗
• InjuryJan 22, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD A PERIOD OF PAIN RELIEF BEFORE COMPLAINING OF A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS MALPOSITIONED AND NOT FULLY ACROSS THE SI JOINT. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT USING CHISELS. HE THEN INSTALLED A NEW IMPLANT OF THE SAME TYPE AND SIZE DEEPER ACROSS THE SI JOINT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 11219469 ↗
• InjuryAug 11, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED UNSATISFACTORY PAIN RELIEF. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS POSITIONED TOO ANTERIORLY AND WAS CLOSE TO THE NEUROFORAMEN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE SHE REMOVED THE INFERIOR POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 10392312 ↗
• InjuryJul 28, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF BUT LATER REPORTED LEFT SIDE RADICULAR PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT HAD PUSHED BONE FRAGMENTS INTO THE SI NERVE ROOT CAUSING RADICULAR PAIN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT AND INSTALLED A NEW IMPLANT OF THE SAME TYPE ADJACENT TO THE EXPLANT VOID. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 10336342 ↗
• InjuryJul 20, 2020Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED SI JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE CAUDAL POSITIONED IMPLANT WAS MALPOSITIONED AND NOT FULLY ACROSS THE SI JOINT. THREE WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON REMOVED THE CAUDAL POSITIONED IMPLANT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 10295780 ↗
• InjuryJun 1, 2020Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR A FEW MONTHS BEFORE REPORTING TO A NEW SURGEON WITH COMPLAINTS OF GLUTEAL MUSCLE PAIN. THE SURGEON DETERMINED THAT THE CAUDAL POSITIONED IMPLANT WAS MALPOSITIONED TOO POSTERIORLY AND WAS INEFFECTIVE. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE LOOSE. IN (B)(6) 2020, THE SURGEON REMOVED THE CAUDAL IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. HE THEN INSTALLED A NEW IMPLANT OF THE SAME TYPE IN A BETTER POSITION TO HELP FIXATE THE SI JOINT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN COMPLAINTS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 10105326 ↗
• InjuryJul 8, 2019Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED A RECURRENCE OF SI JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE CAUDAL POSITIONED IMPLANT WAS NOT PLACED OPTIMALLY POSSIBLY DUE IN PART TO THE PATIENT'S SMALL STATURE. IN (B)(6) 2019, THE SURGEON REMOVED THE CAUDAL POSITIONED IMPLANT AND REPLACED IT WITH A LONGER IMPLANT OF THE SAME TYPE IN A BETTER POSITION. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 8769671 ↗
• InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD A PERIOD OF PAIN RELIEF BEFORE COMPLAINING OF A RECURRENCE OF SI JOINT PAIN SYMPTOMS. DIAGNOSTIC SI JOINT INJECTIONS RELIEVED THE PAIN AROUND THE MOST DISTAL IMPLANT, SO THE PATIENT REQUESTED TO HAVE THAT IMPLANT REMOVED. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE MALPOSITIONED OR LOOSE. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 8632032 ↗
• InjurySep 26, 2018Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAS A DYSMORPHIC SACRUM. DURING THE PROCEDURE, THE CAUDAL POSITIONED IMPLANT WAS INADVERTENTLY ADVANCED INTO THE PELVIS BY THE INSTALLATION OF THE MIDDLE IMPLANT. THE PATIENT DID NOT REPORT ANY PAIN COMPLAINTS. LATER THAT SAME DAY, A REVISION PROCEDURE WAS PERFORMED WHERE THE MALPOSITIONED CAUDAL IMPLANT WAS REMOVED FOR SAFETY REASONS ONLY AS THERE WERE NO PAIN COMPLAINTS. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED.

  Patient problems: Arthralgia

  MAUDE report 7911482 ↗