iFuse Implant System 7050M-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00851085007367), received between Oct 5, 2017 and Oct 28, 2021 — classified as 32 injuries.

The most frequently reported specific device problem is “Malposition of Device” (32 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE INSTALLED. THE SURGEON PERFORMED AN ADDITIONAL PROCEDURE TO ADD AN IMPLANT OF THE SAME TYPE IN A MORE INFERIOR POSITION AND A BONE IMPLANT IN (B)(6) 2020 TO HELP FIXATE THE JOINT. THE PATIENT LATER REPORTED RIGHT SIDE RADICULAR PAIN. THE SURGEON BELIEVED THAT THE METALLIC IMPLANT ADDED IN (B)(6) 2020 MAY HAVE BEEN IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. NO ADDITIONAL HARDWARE WAS ADDED. NONE OF THE OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE SURGEON PERFORMED AN L5-S1 LAMINECTOMY CONCURRENTLY WITH REVISION. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 12713088 ↗
• InjuryOct 1, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED, ONE ROD AND TWO SCREWS). THE PATIENT LATER COMPLAINED OF LEG AND GROIN PAIN. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED ROD WAS BREACHING ANTERIORLY CAUSING L5 NERVE ISSUES BASED ON CT RESULTS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT ROD AND REINSTALLED IT IN A NEW TRAJECTORY. THE PATIENT'S PAIN COMPLAINTS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 12566166 ↗
• InjuryAug 26, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS TOO PROUD OF THE ILIUM, IRRITATING THE MUSCLE. IN (B)(6), THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS. THE EXPLANT HOLE WAS NOT FILLED WITH BONE GRAFT AND NO NEW HARDWARE WAS ADDED. 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 12375294 ↗
• InjuryAug 20, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF FOOT PAIN AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS MALPOSITIONED, PLACED TOO ANTERIORLY. FIVE DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. NO BONE GRAFT OR ADDITIONAL HARDWARE WAS ADDED TO THE EXPLANT VOID. HE THEN INSTALLED A NEW, SHORTER, IMPLANT OF THE SAME TYPE IN A MORE POSTERIOR POSITION. 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 12351183 ↗
• InjuryAug 13, 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 HAD PAIN RELIEF FOR TWO WEEKS BEFORE COMPLAINING OF RADICULAR PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE LEFT SIDE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE LEFT SIDE SUPERIOR POSITIONED IMPLANT TO RELIEVE ANY POSSIBLE NERVE IMPINGEMENT. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. NO NEW HARDWARE WAS ADDED. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 12321600 ↗
• InjuryJul 15, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD A PREVIOUS LUMBAR FUSION. IN (B)(6) 2021, THE SURGEON PERFORMED A LEFT SIDE SI JOINT ARTHRODESIS ON THE PATIENT WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF, BUT LATER REPORTED NEW RADICULAR PAIN. IT WAS DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS MALPOSITIONED TOO CEPHALAD AND NOT FULLY CONTAINED WITH THE OSSEOUS ENVELOPE OF THE SACRAL ALA RESULTING IN FRACTURES OF THE SACRAL ALAR CORTICAL WALL. THE TIP OF THE IMPLANT WAS OUTSIDE OF THE SACRUM AND IN THE PROXIMITY OF THE L5 NERVE ROOT CAUSING RADICULAR PAIN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS. HE THEN INSTALLED A SHORTER IMPLANT OF THE SAME TYPE IN AN INFERIOR POSITION BELOW THE EXISTING IMPLANTS. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S L5 PAIN SYMPTOMS IMPROVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Bone Fracture(s); Undesired Nerve Stimulation

  MAUDE report 12178182 ↗
• InjuryJul 12, 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 LATER REPORTED COMPLAINTS OF NEW RADICULAR PAIN. THE SURGEON DETERMINED THAT THE MIDDLE AND INFERIOR POSITIONED IMPLANTS WERE IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. TWO DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE MIDDLE POSITIONED IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. HE THEN BACKED UP, BUT DID NOT REMOVE, THE INFERIOR POSITION IMPLANTS A FEW MILLIMETERS. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 12150362 ↗
• InjuryJun 29, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF POST-OP RADICULAR PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT. 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: Undesired Nerve Stimulation

  MAUDE report 12089766 ↗
• InjuryMay 3, 2021Malposition of Device; Malposition of Device

  IN (B)(6) 2020, THE PATIENT HAD RIGHT SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON INITIALLY THOUGHT THAT THERE MAY HAVE BEEN SLIGHT LUCENCY AROUND THE DISTAL END OF THE SUPERIOR POSITIONED IMPLANT. THE IMPLANT MAY ALSO HAVE BEEN MALPOSITIONED SLIGHTLY TOO ANTERIOR. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE SUPERIOR POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. THE EXPLANT SHOWED SIGNIFICANT GOOD BONE GROWTH ALONG ITS ENTIRE LENGTH AND WAS NOT LOOSE. HE 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 NOT KNOWN.

  Patient problems: Arthralgia

  MAUDE report 11767312 ↗
• InjuryApr 29, 2021Malposition of Device; Malposition of Device

  IN (B)(6) 2020, THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOLLOWING THE INITIAL SURGERY BUT LATER REPORTED RADICULAR PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE MIDDLE POSITIONED IMPLANT WAS TOO LONG AND MALPOSITIONED AND WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE FIRST REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS SOLELY TO ACCESS THE MIDDLE IMPLANT. THERE WERE NO COMPLAINTS ABOUT THE SUPERIOR POSITIONED IMPLANT. HE THEN REMOVED THE MIDDLE POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE AND INSTALLED A SHORTER IMPLANT OF THE SAME TYPE INTO THE EXPLANT VOID. HE ALSO INSTALLED A NEW IMPLANT OF THE SAME TYPE IN THE SUPERIOR EXPLANT VOID. THE PREEXISTING INFERIOR POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 11749919 ↗
• InjuryMar 2, 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 COMPLAINED OF RADICULAR PAIN SYMPTOMS FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR 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 NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 11402483 ↗
• InjuryFeb 5, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE SURGEON LATER DETERMINED VIA CT SCAN THAT CRANIAL POSITIONED IMPLANT WAS MALPOSITIONED TOO DORSALLY. THE PATIENT DID NOT REPORT ANY PAIN COMPLAINTS AT THE TIME. THE SURGEON DECIDED TO REMOVE THE IMPLANT TO AVOID ANY POSSIBLE FUTURE COMPLICATIONS DUE TO ITS MALPOSITIONING. ONE WEEK AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT IS DOING WELL FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 11289768 ↗
• InjuryDec 7, 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 COMPLAINED OF RADICULAR PAIN LIKE SYMPTOMS. THE SURGEON DECIDED TO REMOVE THE SUPERIOR POSITIONED IMPLANT THAT MAY HAVE BEEN IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. NO BONE GRAFT OR NEW HARDWARE WAS ADDED TO THE EXPLANT VOID. 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 10961999 ↗
• InjuryOct 13, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE ONLY TWO IMPLANTS WERE INSTALLED DUE TO A DYSMORPHIC SACRUM. THE PATIENT REPORTED LEFT SIDE RADICULAR PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE LEFT SIDE INFERIOR POSITIONED IMPLANT MAY HAVE BEEN IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. FIVE DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE LEFT SIDE INFERIOR POSITIONED AND REPLACED IT WITH A SHORTER 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: Undesired Nerve Stimulation

  MAUDE report 10675063 ↗
• InjuryOct 13, 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'S INITIAL SI JOINT PAIN RESOLVED, BUT HE LATER REPORTED PAIN AROUND THE SURGICAL SITE. THE SURGEON DETERMINED THAT THE CAUDAL POSITIONED IMPLANT WAS TOO PROUD OF THE ILIUM CAUSING PAIN AROUND THE SURROUNDING TISSUES. IN (B)(6) 2020, THE SURGEON REMOVED THE CAUDAL POSITIONED IMPLANT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SUBSIDED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 10674841 ↗
• InjurySep 4, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT REPORTED TOE NUMBNESS, BUT NO PAIN, FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. TWO DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT AND THEN INSTALLED A SHORTER IMPLANT OF THE SAME TYPE IN A NEW POSITION. 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 10495401 ↗
• InjurySep 2, 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 REPORTED LEFT SIDE RADICULAR PAIN SYMPTOMS FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. NO BONE GRAFT OR HARDWARE WAS INSTALLED. 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 10484801 ↗
• InjuryApr 9, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAS A DYSMORPHIC SACRUM. THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT DID WELL AFTER THE INITIAL PROCEDURE BUT LATER REPORTED LEFT SIDE RADICULAR PAIN AFTER A SLIGHT FALL. THE SURGEON DETERMINED THAT THE LOWER POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE LOWER POSITIONED IMPLANT WITH CHISELS AS IT WAS SOLIDLY FIXED IN BONE. HE THEN INSTALLED A SHORTER AND WIDER IMPLANT OF THE SAME TYPE INTO 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 9944095 ↗
• InjuryMar 31, 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 REPORTED RIGHT SIDE RADICULAR PAIN AFTER THE PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. LATER THAT SAME DAY, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT AND INSTALLED A SHORTER IMPLANT OF THE SAME TYPE INTO THE EXPLANT VOID. 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 9908586 ↗
• InjuryFeb 11, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED RIGHT SIDE FOOT PAIN. THE SURGEON WAS NOT CONVINCED THAT THE IMPLANTS WERE THE SOURCE OF THE RADICULAR PAIN SYMPTOMS, BUT HE DECIDED TO BACK UP THE SUPERIOR POSITIONED IMPLANT REGARDLESS. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE ATTEMPTED TO BACK OUT, BUT NOT REMOVE, THE SUPERIOR POSITIONED IMPLANT A FEW MILLIMETERS, BUT HE WAS ONLY ABLE TO BACK OUT THE IMPLANT VERY SLIGHTLY IF AT ALL 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 9693737 ↗
• InjuryFeb 10, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF LEG PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE MIDDLE IMPLANT HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE MIDDLE IMPLANT AND REPLACED IT WITH A SHORTER 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: Undesired Nerve Stimulation

  MAUDE report 9688874 ↗
• InjuryFeb 5, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD THREE MONTHS OF PAIN RELIEF BEFORE COMPLAINING OF RIGHT SIDE RADICULAR LEG PAIN. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT USING CHISELS. 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 9673102 ↗
• InjurySep 19, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF LEFT LEG PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE MOST SUPERIOR POSITIONED IMPLANT WAS INSTALLED BACKWARDS AND HAD BREACHED THE NEUROFORAMEN. THREE WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. 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 9087402 ↗
• InjuryJul 19, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD INITIAL SI JOINT PAIN RELIEF BEFORE REPORTING NEW PAIN TEN DAYS AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. 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 8809646 ↗
• InjuryJul 19, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD BILATERAL SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED ON THE LEFT SIDE AND TWO ON THE RIGHT. THE PATIENT HAD PAIN RELIEF FOR FOUR MONTHS BEFORE EXPERIENCING A RECURRENCE OF PAIN SYMPTOMS ON THE LEFT SIDE. THE SURGEON DETERMINED THAT THE CAUDAL POSITIONED IMPLANT WAS TOO PROUD OF THE ILIUM CAUSING PAIN. THE SURGEON DID NOT INDICATE THAT ANY OF THE IMPLANTS WERE LOOSE. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CAUDAL POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. NO OTHER HARDWARE WAS INSTALLED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 8809363 ↗