Modulus 1775850Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00887517913425), received between Jul 25, 2022 and Apr 21, 2026 — classified as 1 injury, 36 malfunctions.

The most frequently reported specific device problem is “Fracture” (37 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Fracture

  THE TIP OF INSERTER BROKE OFF IN IMPLANT AND TIP WAS NOT ABLE TO BE RETRIEVED. NO ADVERSE EFFECT TO PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24944020 ↗
• MalfunctionApr 20, 2026Fracture

  IT WAS REPORTED THAT THE TIP OF THE MODULUS XLIF INSERTER WAS SEVERED. THE TIP WAS BROKEN IN THE CAGE WHILE BEING INSERTED AND IT WAS LEFT SECURELY IN THE CAGE AND COULD NOT BE REMOVED. THE PATIENT IS DOING WELL, NO ADVERSE EFFECT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24932307 ↗
• MalfunctionApr 16, 2026Fracture

  IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE OFF IN THE CAGE WHILE BEING INSERTED DURING A XLIF CASE. THE TIP WAS LEFT IN THE PATIENT, AND THE CAGE WAS FURTHER ¿TAMPED¿ IN TO PLACE THE CAGE. THE FRACTURE TIP IS FULLY INSERTED AND STUCK INTO THE CAGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24903943 ↗
• MalfunctionFeb 2, 2026Fracture

  IT WAS REPORTED THAT WHILE INSERTING MODULUS IMPLANT, THE INNER THREADED PIECE OF THE INSERTER THAT INTERACTS WITH THE THREADED HOLE IN THE IMPLANT BROKE OFF AND STAYED IN IMPLANT. THEY COULD NOT GET THE IMPLANT OUT SINCE IT WAS MORE THAN HALFWAY IN AND SO WE JUST TAMPED IMPLANT FURTHER INTO DISC SPACE AND LEFT THE BROKEN PIECE IN THE IMPLANT. NOTHING WAS PUT OVER THE TIP; IT¿S THREADED ALL THE WAY INTO THE IMPLANT AND BROKE OFF. NO REVISION NECESSARY AND AS OF NOW NO REPORTED EFFECTS TO PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24236466 ↗
• MalfunctionSep 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A MODULUS XLW BROKE OFF INSIDE THE CAGE AND COULD NOT BE RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23146547 ↗
• MalfunctionSep 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF A MODULUS XLW INSERTER BROKE OFF INSIDE THE IMPLANTED CAGE AND WAS UNABLE TO BE RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23016045 ↗
• MalfunctionFeb 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ANTERIOR LONGITUDINAL INTERBODY FUSION PROCEDURE FROM L2 TO S1. DURING THE PROCEDURE THE THREADED TIP OF THE INSERTER FRACTURED OFF DURING IMPLANT INSERTION AT THE L3-L4 LEVEL. THE FRACTURED PORTION WAS RETAINED IN THE IMPLANT SO THE SURGEON OPTED TO LEAVE THE PORTION IN SITU. NO ADDITIONAL PATIENT OR PROCEDURE IMPACT WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21333251 ↗
• MalfunctionDec 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING INTERBODY IMPLANT INSERTION THE DISTAL, THREADED TIP, OF THE DEVICE FRACTURED OFF INTO THE ENGAGED IMPLANT AND COULD NOT BE RETRIEVED. THE FRACTURED PORTION WAS RETAINED IN THE IMPLANT SO THE SURGEON OPTED TO LEAVE THE PORTION IN SITU. NO FURTHER PATIENT IMPACT WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21039802 ↗
• MalfunctionDec 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR SPINAL PROCEDURE AND WHILE DURING INTERBODY IMPLANT INSERTION THE DISTAL, THREADED TIP, OF THE DEVICE FRACTURED OFF INTO THE ENGAGED IMPLANT AND COULD NOT BE RETRIEVED. THE FRACTURED PORTION WAS RETAINED IN THE IMPLANT SO THE SURGEON OPTED TO LEAVE THE PORTION IN SITU. NO FURTHER PATIENT OR CASE IMPACT WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20930590 ↗
• MalfunctionDec 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT WHILE INSERTING THE INTERBODY IMPLANT DURING AN EXTREME LATERAL INTERBODY FUSION CASE, THE DISTAL, THREADED, TIP OF THE DEVICE FRACTURED OFF INTO THE ENGAGED IMPLANT AND COULD NOT BE RETRIEVED. THE FRACTURED PORTION WAS RETAINED IN THE IMPLANT SO THE SURGEON OPTED TO LEAVE THE PORTION IN SITU. NO FURTHER PATIENT IMPACT WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20857164 ↗
• MalfunctionDec 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING INTERBODY IMPLANT INSERTION THE DISTAL, THREADED TIP, OF THE DEVICE FRACTURED OFF INTO THE ENGAGED IMPLANT AND COULD NOT BE RETRIEVED. THE FRACTURED PORTION WAS RETAINED IN THE IMPLANT SO THE SURGEON OPTED TO LEAVE THE PORTION IN SITU. NO FURTHER PATIENT IMPACT WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20849419 ↗
• MalfunctionSep 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING INTERBODY IMPLANT INSERTION THE DISTAL, THREADED TIP, OF THE DEVICE FRACTURED OFF INTO THE ENGAGED IMPLANT AND COULD NOT BE RETRIEVED. THE FRACTURED PORTION WAS RETAINED IN THE IMPLANT SO THE SURGEON OPTED TO LEAVE THE PORTION IN SITU. NO FURTHER PATIENT IMPACT WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20263727 ↗
• MalfunctionSep 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING INTERBODY IMPLANT INSERTION THE DISTAL, THREADED TIP, OF THE DEVICE FRACTURED OFF INTO THE ENGAGED IMPLANT AND COULD NOT BE RETRIEVED. THE FRACTURED PORTION WAS RETAINED IN THE IMPLANT SO THE SURGEON OPTED TO LEAVE THE PORTION IN SITU. NO FURTHER PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20216024 ↗
• MalfunctionMay 22, 2024Fracture; Fracture

  ON 13 MAY 2024 A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE FROM L3-L4. DURING INTERBODY IMPLANT INSERTION THE DISTAL, THREADED TIP, OF THE DEVICE FRACTURED OFF INTO THE ENGAGED IMPLANT AND COULD NOT BE RETRIEVED. THE FRACTURED PORTION WAS RETAINED IN THE IMPLANT SO THE SURGEON OPTED TO LEAVE THE PORTION IN SITU. NO FURTHER PATIENT IMPACT WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19376626 ↗
• MalfunctionMay 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A LUMBAR PROCEDURE THE DISTAL, THREADED, TIP OF A INTERBODY INSERTER FRACTURED OFF WITHIN THE INTERBODY AND WAS RETAINED IN THE IMPLANT. THE TIP WAS LEFT IN-SITU, EMBEDDED IN THE IMPLANT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19324135 ↗
• MalfunctionFeb 29, 2024Fracture; Fracture

  ON (B)(6) 2024 DURING AN EXTREME LATERAL INTERBODY FUSION AT L3/5 DURING THE CAGE INSERTION AT L3/4 THE INSERTER THREADS SNAPPED. THE THREADS COULD NOT BE RETRIEVED AND WERE LEFT INSIDE THE CAGE IN-SITU. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18812728 ↗
• MalfunctionFeb 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL FOUR (4) LEVEL XLIF PROCEDURE. DURING INSERTION OF THE MODULUS IMPLANT AT THE 3RD LEVEL, L2/3, THE DISTAL THREADED TIP OF THE INSERTER FRACTURED OFF INSIDE THE MODULUS CAGE AND WAS UNABLE TO BE RETRIEVED. THE IMPLANT WAS SLIGHTLY ANTERIOR TO THE INTENDED PLACEMENT; HOWEVER, THE SURGEON WAS CONCERNED THAT REPOSITIONING THE IMPLANT MAY RISK PATIENT SAFETY. AS A RESULT, THE IMPLANT WAS LEFT IN THE ANTERIOR POSITION AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER IMPACT TO THE PATIENT. THE SURGEON PLANS TO MONITOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18681546 ↗
• MalfunctionFeb 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT WHILE MALLETING THE INTERBODY INTO THE DISC SPACE VIA THE INTERBODY INSERTER, THE DISTAL ENGAGEMENT FEATURE OF THE INSERTER FRACTURED OFF INSIDE THE INTERBODY AND COULD NOT BE RECOVERED. THEREFORE, THE FRACTURED PIECE REMAINS IN THE PATIENT, LODGED WITHIN THE INTERBODY. THERE WAS NO PATIENT HARM OR ADVERSE CONSEQUENCE RELATED TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18636785 ↗
• MalfunctionJan 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DISTAL THREADED TIP OF THE INSERTER FRACTURED OFF INSIDE THE INTERBODY WHILE MALLEATING THE INTERBODY FOR PLACEMENT AT L2/3. PER SURGEON DECISION, THE FRACTURED TIP WAS NOT RETRIEVED. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT, USER, OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18508614 ↗
• MalfunctionOct 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING INSERTION OF THE CAGE INTO THE DISC SPACE AT L3/4, THE DISTAL TIP OF THE INSERTER FRACTURED OFF INTO THE CAGE AND COULD NOT BE RECOVERED. THEREFORE, THE INSERTER TIP REMAINS LODGED INSIDE THE CAGE. THERE WAS NO PATIENT HARM OR ADVERSE CONSEQUENCE RELATED TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18044405 ↗
• MalfunctionSep 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING INSERTION OF THE CAGE INTO THE DISC SPACE AT L2/3, THE INSERTER TIP FRACTURED OFF INSIDE THE CAGE AND COULD NOT BE RETRIEVED. THEREFORE, THE INSERTER TIP REMAINS LODGED INSIDE THE IMPLANTED CAGE. THERE WAS NO PATIENT HARM OR ADVERSE CONSEQUENCE RELATED TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17702471 ↗
• MalfunctionSep 7, 2023Fracture; Fracture

  THREADS FOR INSERTER BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17700992 ↗
• MalfunctionAug 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING INSERTION OF THE CAGE INTO THE DISC SPACE, THE DISTAL TIP OF THE INSERTER FRACTURED OFF INTO THE CAGE AND COULD NOT BE RECOVERED. THEREFORE, THE INSERTER TIP REMAINS LODGED INSIDE THE IMPLANTED CAGE. THERE WAS NO PATIENT HARM OR ADVERSE CONSEQUENCE RELATED TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17553523 ↗
• MalfunctionAug 2, 2023Fracture; Fracture

  ON (B)(6) 2023 A PATIENT UNDERWENT A EXTREME LATERAL INTERBODY FUSION PROCEDURE ON UNKNOWN LEVEL OF THE SPINE. DURING THE PROCEDURE THE DISTAL TIP OF INSERTER FRACTURED OFF INTO THE CAGE AND WAS LEFT IN THE PATIENT AS IT WAS DETERMINED INTRAOPERATIVELY THAT IT COULD CAUSE MORE TRAUMA TO THE PATIENT TO EXPLANT THE CAGE OPPOSED TO LEAVING IT COLD WELDED IN THE ENGAGED SCREW. NO PATIENT INJURY OR CONSEQUENCE WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17446007 ↗
• MalfunctionJun 30, 2023Fracture; Fracture

  DURING A SPINAL PROCEDURE THE TIP WAS FRACTURED OFF INSIDE THE CAGE AND LEFT IN-SITU. NO PATIENT INJURY OR CONSEQUENCE WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17238906 ↗