iFuse Implant System 7055M-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00851085007374), received between Jul 17, 2017 and Jan 13, 2022 — classified as 40 injuries.

The most frequently reported specific device problem is “Malposition of Device” (38 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 40 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2022Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF PAIN FOLLOWING A SHORT PERIOD OF PAIN RELIEF AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED MALPOSITIONING OF THE SUPERIOR IMPLANT BASED ON CT IMAGING AND DECIDED TO REMOVE THE SUPERIOR POSITIONED. WITHIN TWO WEEKS OF THE INITIAL PROCEDURE, A DIFFERENT SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED SUPERIOR POSITIONED IMPLANT. NO BONE GRAFT OR ADDITIONAL HARDWARE WAS ADDED. NONE OF THE OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia; Undesired Nerve Stimulation

  MAUDE report 13253298 ↗
• 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 LEG/FOOT PAIN POST-SURGERY DURING RECOVERY. THE SUPERIOR IMPLANT WAS IMPINGING ON THE NEUROFORAMEN. SAME DAY, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE SUPERIOR-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 12887993 ↗
• InjuryNov 17, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT'S INITIAL SI JOINT PAIN SYMPTOMS RESOLVED FOLLOWING THE PROCEDURE, BUT LATER REPORTED RADICULAR PAIN SYMPTOMS. THE SURGEON DECIDED TO REMOVE THE SUPERIOR POSITIONED IMPLANT AND REPLACE IT WITH A SHORTER IMPLANT. 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 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 12832395 ↗
• InjuryOct 20, 2021Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE THREE IMPLANTS WERE INSTALLED ON EACH SIDE. THE PATIENT LATER COMPLAINED OF CONTINUED SI JOINT PAIN. THE PATIENT REPORTED RIGHT SIDE LEG PAINS FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DID NOT DETERMINE THAT ANY OF THE RIGHT SIDE IMPLANTS WERE MALPOSITIONED BUT DECIDED TO REMOVE THE RIGHT SIDE SUPERIOR POSITIONED IMPLANT REGARDLESS. TWO WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE RIGHT SIDE SUPERIOR POSITIONED IMPLANT. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT OR OTHER HARDWARE. 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 12667131 ↗
• InjuryAug 27, 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 LATER COMPLAINED OF LEG PAIN. THE SUPERIOR POSITIONED IMPLANT MAY HAVE BEEN IMPINGING ON THE NEUROFORAMEN. THE X-RAY TAKEN POST-SURGERY REVEALED THAT THE SUPERIOR IMPLANT WAS PLACED TOO HIGH. TWO WEEKS FOLLOWING THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION WHERE HE REMOVED THE SUPERIOR 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 12380262 ↗
• InjuryAug 6, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN JULY WHERE THREE IMPLANTS WERE INSTALLED ON EACH SIDE. THE PATIENT COMPLAINED OF RIGHT SIDE POST-OP RADICULAR PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE RIGHT SIDE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. ONE DAY AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE SHE REMOVED THE RIGHT SIDE 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 PATIENT'S RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 12288359 ↗
• InjuryJul 8, 2021Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2021 WHERE TWO IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED COMPLAINTS OF NEW RADICULAR PAIN. THE SURGEON DETERMINED THAT THE INFERIOR POSITIONED IMPLANT WAS IMPINGING ON THE S1 NERVE ROOT CAUSING RADICULAR PAIN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE INFERIOR POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. HE THEN INSTALLED A NEW, SHORTER IMPLANT OF THE SAME TYPE INTO THE EXPLANT VOID. THE PREEXISTING SUPERIOR POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 12135199 ↗
• InjuryJun 29, 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 LATER COMPLAINED OF A RECURRENCE OF SI-JOINT PAIN SYMPTOMS AFTER A FALL. THE SURGEON THOUGHT THAT THE SUPERIOR POSITIONED IMPLANT WAS LOOSE. APPROXIMATELY 10 DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT AND ADDED A NEW IMPLANT OF THE SAME TYPE IN A MORE POSTERIOR POSITION. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS UNKNOWN.

  Patient problems: Arthralgia

  MAUDE report 12089757 ↗
• InjuryJun 17, 2021Malposition of Device; Malposition of Device

  THE PATIENT IS OSTEOPOROTIC AND HAS HAD A PREVIOUS LUMBAR FUSION. IN (B)(6) 2020, THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT DID WELL INITIALLY BEFORE COMPLAINING OF RADICULAR PAIN AFTER A FALL IN (B)(6) 2021. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT HAD SHIFTED AFTER THE FALL AND HAD BREACHED THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT WITH CHISELS AS IT WAS SOLIDLY FIXED IN BONE. BONE WAX WAS PLACED IN 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 12017983 ↗
• InjuryMay 19, 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 LEG PAIN FOLLOWING THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPLANTED TOO DEEP AND HAD BREACHED THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE BACKED-UP, BUT DID NOT REMOVE, THE SUPERIOR POSITIONED APPROXIMATELY TWO MILLIMETERS TO RELIEVE THE NERVE IMPINGEMENT. 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 11849879 ↗
• InjuryMar 29, 2021Malposition of Device; Malposition of Device

  IN (B)(6) 2021, THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF RADICULAR PAIN SYMPTOMS IMMEDIATELY FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. LATER THAT SAME DAY, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. THE EXPLANT VOID WAS NOT FILLED WITH BONE GRAFT. HE THEN INSTALLED A SHORTER IMPLANT OF THE SAME TYPE IN A MORE INFERIOR POSITION BELOW THE INITIAL IMPLANTS. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S SI JOINT AND RADICULAR PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 11586831 ↗
• InjuryDec 5, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. HE PATIENT'S SI JOINT PAIN RESOLVED BUT THEY LATER REPORTED RADICULAR LEG PAIN AND FOOT NUMBNESS. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN SYMPTOMS. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE SHE REMOVED THE SUPERIOR POSITIONED IMPLANT AND PACKED THE EXPLANT VOID WITH BONE GEL. 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 10954394 ↗
• InjuryDec 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 LATER REPORTED RADICULAR LEG PAIN. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. NO NEW HARDWARE OR BONE GRAFT WAS INSTALLED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 10932237 ↗
• InjuryNov 16, 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 COMPLAINED OF POST-OPERATIVE RADICULAR PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE MOST SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. TWO DAYS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE BACKED-UP, BUT DID NOT REMOVE, THE SUPERIOR POSITIONED IMPLANT APPROXIMATELY FIVE MILLIMETERS TO RELIEVE THE NERVE IMPINGEMENT. HE THEN ADDED AN ADDITIONAL IMPLANT OF THE SAME TYPE IN A SUPERIOR 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 10849330 ↗
• InjuryAug 19, 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 HAD SI JOINT PAIN RELIEF FOR FIVE MONTHS, BUT THEN REPORTED RIGHT SIDE RADICULAR PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NEUROFORAMEN CAUSING RADICULAR PAIN. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS. 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 10429138 ↗
• InjuryMar 17, 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 PAIN AROUND THE SURGICAL SITE AFTER THE INITIAL PROCEDURE. THE SURGEON DETERMINED THAT THE MOST CAUDAL POSITIONED IMPLANT WAS TOO PROUD OF THE ILIUM AND IRRITATING THE SURROUNDING TISSUES. ONE WEEK AFTER THE INITIAL PROCEDURE, THE SURGEON REMOVED THE CAUDAL POSITIONED IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT IS DOING WELL FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Arthralgia

  MAUDE report 9838579 ↗
• InjuryJan 13, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT REPORTED RADICULAR LEG PAIN FOLLOWING 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 IMPINGING IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. 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 9581375 ↗
• InjuryJan 2, 2020Malposition of Device; Malposition of Device

  THE PATIENT HAD LEFT SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED LEFT SIDE RADICULAR PAIN. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON 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 9539070 ↗
• InjuryNov 4, 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 LATER COMPLAINED OF LEFT SIDE RADICULAR PAIN. THE SURGEON DETERMINED THAT THE MIDDLE POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED BOTH THE MIDDLE POSITIONED IMPLANT WITH CHISELS AS IT WAS SOLIDLY FIXED IN BONE. HE THEN 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 9272170 ↗
• InjuryOct 24, 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 LATER COMPLAINED OF LEFT SIDE RADICULAR PAIN. THE SURGEON DETERMINED THAT THE CAUDAL POSITIONED IMPLANT HAD BREACHED THE S2 NEUROFORAMEN. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE CAUDAL IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 9234558 ↗
• InjuryOct 21, 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 HAS A DYSMORPHIC SACRUM. THE PATIENT LATER COMPLAINED OF CONTINUED RADICULAR PAIN. THE SURGEON COULD NOT DEFINITELY DETERMINE IF THE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN, BUT THE PATIENT WANTED IT REMOVED ANYWAY. IT WAS NOTED THAT THE PATIENT HAD LEFT LEG PAIN BEFORE THE INITIAL PROCEDURE AS WELL. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 9215992 ↗
• InjuryOct 17, 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 LATER COMPLAINED OF LEFT-SIDE RADICULAR PAIN. THE SURGEON DETERMINED THAT THE MOST SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE S1 NEUROFORAMEN. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS AND REPLACED IT WITH A SHORTER IMPLANT OF THE SAME TYPE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 9202902 ↗
• InjuryAug 29, 2019Malposition of Device; Malposition of Device

  THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED ON EACH SIDE. THE PATIENT'S SI JOINT PAIN RESOLVED BUT COMPLAINED OF RIGHT LEG PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE MOST SUPERIOR POSITIONED IMPLANT ON THE RIGHT SIDE WAS IMPINGING ON THE S1 NEUROFORAMEN CAUSING RADICULAR PAIN. TWO WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE BACKED UP THE RIGHT SIDE SUPERIOR POSITIONED IMPLANT APPROXIMATELY TWO CENTIMETERS. THE IMPLANT WAS NOT REMOVED. 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 8947103 ↗
• InjuryAug 2, 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 RADICULAR PAIN IMMEDIATELY AFTER THE PROCEDURE. THE SURGEON DETERMINED THAT THE MOST SUPERIOR POSITIONED IMPLANT WAS IMPINGING ON THE NERVE ROOT. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT AND PLACED 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 8855485 ↗
• InjuryJul 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 SLIGHT LEG PAIN POST-OP. THE SURGEON DETERMINED THAT THE SUPERIOR POSITIONED IMPLANT HAD BREACHED THE NEUROFORAMEN. A FEW HOURS AFTER THE INITIAL PROCEDURE, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE PATIENT'S PAIN SYMPTOMS RESOLVED FOLLOWING THE REVISION PROCEDURE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 8809602 ↗