Superion Interspinous Spacer 10mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884662000246), received between Sep 13, 2017 and Oct 3, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A SUPERION DEVICE CRASHED A GOLF CART AND FELL. DURING A STEROID INJECTION A BROKEN CAM LOBE ON THE SPACER WAS DETECTED. THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS CAUSED BY THE BROKEN CAM LOBE, AND THE DEVICE REMAINS IMPLANTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23214482 ↗
• InjuryJul 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENTS SPINAL SUPERION INDIRECT DECOMPRESSION (ID) SPACER HAS BECOME DISLODGED. IT WAS NOTED THAT NO ACTION WAS TAKEN AT THIS TIME PER THE PHYSICIAN. ADDITIONAL INFORMATION WAS NOT PROVIDED DESPITE GOOD FAITH EFFORT ATTEMPTS.

  Patient problems: Pain

  MAUDE report 19736209 ↗
• InjurySep 26, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE TO EXPLANT THE INDIRECT DECOMPRESSION (ID) SPACER. THE PATIENT HAD GOTTEN INTO A GOLF CART ACCIDENT AND BROKEN ONE OF THE LEGS OFF THE SPACER. ALTHOUGH IT WAS NOT EASY TO GET THE SPACER OUT, THE PHYSICIAN SUCCESSFULLY EXPLANTED THE SPACER AND THE BROKEN LEG COMPONENT. THE PATIENT WAS REIMPLANTED WITH A NEW SPACER AT THE SAME LEVEL AND AN ADDITIONAL NEW SPACER WAS ADDED AT L 3-4 LUMBAR VERTEBRAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17819820 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THIS REPORTER RECEIVED A TELEPHONE CALL FROM THE WIFE OF A PATIENT WHO WAS TREATED AT TWO (2) LEVELS WITH THE SUPERION IDS. SHE REPORTED THAT 8-10 DAYS AFTER TREATMENT, HER HUSBAND (THE PATIENT) DEVELOPED SEVERE HIP AND LEG PAIN. SHE STATED THAT REMOVAL OF THE DEVICES IS SCHEDULED IN THE NEAR FUTURE, AND ASKED IF REMOVAL WOULD RESOLVE THESE SYMPTOMS. SUBSEQUENT COMMUNICATIONS WITH THE IMPLANTING PHYSICIAN REVEALED THAT THE PATIENT ORIGINALLY PRESENTED WITH "CLASSIC" SYMPTOMS OF MODERATE NEUROGENIC CLAUDICATION ASSOCIATED WITH LUMBAR SPINAL STENOSIS. FURTHER, HE NOTED THAT SUBSEQUENT RADIOGRAPHIC IMAGING ESTABLISHES THAT THE IMPLANTS REMAIN "PERFECTLY PLACED".

  Patient problems: Pain; Therapeutic Response, Decreased

  MAUDE report 7783079 ↗
• MalfunctionSep 13, 2017Fracture; Patient-Device Incompatibility; Activation, Positioning or Separation Problem; Material Integrity Problem; Fracture; Patient-Device Incompatibility; Activation, Positioning or Separation Problem; Material Integrity Problem

  MANUFACTURER'S CASE COVERAGE REPRESENTATIVE NOTED THAT DURING A CASE PERFORMED ON (B)(6), "UPON REMOVAL OF IMPLANT, WE DISCOVERED THAT THE INFERIOR WING HAD COMPLETELY SHEARED OFF. WHEN ATTEMPTING TO REINSERT A NEW SUPERION, WE DISCOVERED THE PATIENT'S ANATOMY WAS NOT CONDUCIVE TO THE IMPLANT. WHEN TAMPING IT DOWN, IT CAUSED THE IMPLANT TO ROTATE AND TORQUE TO THE SIDE WHICH CAUSED THE WING TO BREAK OFF." THIS WAS INTERPRETED BY MANUFACTURER AS AN INTRA-OPERATIVE IMPLANT FAILURE (BREAKAGE) ATTRIBUTABLE TO INCOMPATIBLE ANATOMY, BUT BECAUSE THERE WERE NO ADVERSE PATIENT SEQUELAE, IT WAS NOT A REPORTABLE EVENT. SUBSEQUENT INFORMATION RECEIVED FROM THE RESPONSIBLE SALES REPRESENTATIVE ON (B)(6), HOWEVER, ESTABLISHED THAT THE (B)(6), PROCEDURE WAS, IN FACT, A REOPERATION SCHEDULED TO REMOVE AND REPLACE AN IMPLANT ORIGINALLY PLACED ON (B)(6), WHICH POST-OPERATIVE X-RAYS SUGGESTED TO THE TREATING PHYSICIAN WAS "NOT CORRECTLY PLACED." IT WAS THIS IMPLANT THAT WAS FOUND, DURING THE (B)(6) REOPERATION, TO HAVE BROKEN. THE FACT THAT REOPERATION WAS REQUIRED TO CORRECT THE ORIGINAL TREATMENT NOW WARRANTS REPORTING.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6863379 ↗