Anteralign Spinal System with Titan nanoLock Surface technology NAV4680003Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00763000204334), received between Aug 29, 2022 and Sep 24, 2026 — classified as 62 malfunctions.

The most frequently reported specific device problem is “Break” (51 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 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break

  Information was received from a health care provider via a manufacturing representative regarding a product identified during intra-operative use. It was reported that the inserter threaded onto the trial; however, during the trialing process, the inserter threads broke off, leaving the trial in the patient. Several instruments were required to remove the trial. As a result, the inserter was broken, and broken threads remained stuck inside the trial. Patient symptoms were unknown. No further complications were reported or anticipated.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885255 ↗
• MalfunctionSep 22, 2026Break

  Information was received from healthcare provider (HCP) via a manufacturer representative regarding a Patient undergoing Spinal ther apy. It was reported that the threaded tip of the inserter broke off while trialing. Another inserter was used to remove the trial. Patient involved did not experience any symptoms as a consequence of this event. There were no further complications reported regarding the event. Additional Information received stated that the procedure in question was OLIF( Oblique Lumbar Interbody Fusion) procedure. It was stated that the sheared off tip of the inserter got stuck inside the trial. No further complications were reported regarding this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850274 ↗
• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50293547 ↗
• MalfunctionJun 9, 2026Break

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR OBLIQUE LATERAL INTERBODY FUSION(OLIF) AND L5-L2 LEVELS WERE IMPLANTED AND POSTERIOR SPINAL FUSION (PSF) FOR T10-PELVIS LEVEL IMPLANT. IT WAS REPORTED THAT THE THREADS APPEARED TO BE BROKEN OFF AND THE INSTRUMENTS WERE USED PREVIOUSLY WITHOUT ANY MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25439248 ↗
• MalfunctionMay 15, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE THREADED INSERTER BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. 2026-APR-26_E1 (REP): ADDITIONAL INFORMATION RECEIVED THAT THE INSTRUMENT AWL WORN DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25180589 ↗
• MalfunctionApr 6, 2026Break

  INFORMATION RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING TWO DEVICES USED FOR SPINAL THERA PY. IT WAS REPORTED THAT INSERTER BECAME LOOSE AND BROKE OFF IN THE TRIAL AND A PIECE OF THE INSERTER IS STUCK IN THE CONNECTION HOLE OF THE TRIAL. THERE WERE NO PATIENT SYMPTOMS REPORTED IN THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787448 ↗
• MalfunctionMar 13, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING A SPINAL PROCEDURE, THE THREADED TIP OF THE INSERTER BROKE OFF DURING THE TRIALING PROCESS, RESULTING IN THE TRIAL BECOMING STUCK IN-BETWEEN THE L4/5 VERTEBRAL BODIES. THE INSERTER AND TRIAL BROKE OFF IN THE PATIENT AT THE L4/5 DISC SPACE DURING THE PROCEDURE. THE SURGEON WAS ABLE TO REMOVE THE TRIAL FROM THE VERTEBRAL BODIES WITHOUT INCIDENT AND SUBSEQUENTLY USED A DIFFERENT INSERTER TO PLACE THE INTERBODY DEVICE. THERE WERE NO PATIENT COMPLICATIONS OR SYMPTOMS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE REPORTED DEVICE HAS BEEN ALREADY USED BEFORE PRIOR TO THIS EVENT. THE THREADED PART OF THE INSERTER BROKE OFF INTO THE TRIAL. TRIAL IS NOW DAMAGED DUE TO THE DIFFERENT TYPES OF INSTRUMENTS USED TO DISLODGE THE TRIAL FROM DISC SPACE. THE PRE-OP DIAGNOSIS WAS L4/5 DISC DEGENERATION WITH A GRADE 1 SPONDYLOLISTHESIS. L4/5 OLIF WAS THE PROCEDURE AND L4/5 DISC SPACE IS WHERE THE TRIAL BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24587982 ↗
• MalfunctionMar 13, 2026Break; Mechanics Altered

  INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT A TRIAL WAS STUCK ON THE INSERTER, AND THE INSERTER SNAPPED WHEN DISENGAGING THE TRIAL. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24587881 ↗
• MalfunctionMar 12, 2026Break

  INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT INSTRUMENTS WERE FOUND BROKEN IN A STORAGE UNIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579748 ↗
• MalfunctionMar 12, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INTERNAL SLEEVE PIN OF TWO INSERTERS WERE BROKE. THERE WERE NO FURTHER PATIENT COMPLICATIONS OR SYMPTOMS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579564 ↗
• MalfunctionMar 12, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INTERNAL SLEEVE PIN OF TWO INSERTERS WERE BROKE. THERE WERE NO FURTHER PATIENT COMPLICATIONS OR SYMPTOMS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579117 ↗
• MalfunctionMar 11, 2026Break

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT TRIAL IS STUCK ONTO INSERTER WHICH SEEMS BROKEN TOO. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE DEVICE APPEARS MAYBE THE TRIAL INSERTER IS NOW BROKEN BECAUSE THE WHEEL KNOB ON THE INSERTER JUST SPINS AND DOESN¿T LOOSEN THE THREADED DIP ANYMORE HENCE WHY THE TRIAL IS STILL STUCK TO IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575383 ↗
• MalfunctionMar 10, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER AND HANDLES WERE BROKEN, THE DRIVER GOT STUCK ON A SCREW. THERE WERE NO PATIENT SYMPTOMS AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE DRIVER WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557241 ↗
• MalfunctionJan 20, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING AN INSERTER. IT WAS REPORTED THAT INNER THREAD WAS NOT OPERATING CORRECTLY. SCRUB TECH NOTICED BEFORE THE CASE BEGAN ON THE STERILE FIELD. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115379 ↗
• MalfunctionJan 5, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR A SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER WOULD NOT LOOSEN ENOUGH TO RELEASE THE TRAIL, AND THE TRIAL BECAME STUCK ON THE INSERTER AND COULD NOT BE REMOVED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954539 ↗
• MalfunctionJan 1, 2026Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED IN A SPINAL THERAPY. IT WAS REPORTED THAT WHEN REMOVING THE TRAIL FROM THE INSERTER, THE THREADS ON THE INSERTER BROKE OFF INSIDE THE TRIAL. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE TRAIL WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23940929 ↗
• MalfunctionDec 16, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR OBLIQUE LATERAL INTERBODY FUSION SPINAL THERAPY. LEVELS IMPLANTED AT L3-L5. IT WAS REPORTED THAT THE THREADED TIP OF THE INSERTER BROKE OFF INSIDE THE TRIAL. THE TRIAL IS NOT BROKEN OR DAMAGED, BUT THE THREADED INSERTER TIP IS BROKEN INSIDE IT. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23813498 ↗
• MalfunctionNov 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSERTER. IT WAS REPORTED THAT THEE INSER TER¿S INNER SHAFT DISLODGED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654176 ↗
• MalfunctionNov 13, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE WHEN LOADING THE TRIAL ON THE INSERTER. NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS WAS DURING AN OLIF (OBLIQUE LUMBAR INTERBODY FUSION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23540794 ↗
• MalfunctionOct 15, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A INSERTER USED FOR SPINAL THERAPY. IT WAS R EPORTED THAT THE THREADED PORTION OF THE INSERTER BROKE WHEN ATTEMPTING TO DISENGAGE THE INSERTER FROM THE IMPLANT ON THE BACK TABLE. THERE WAS NO PATIENT INVOLVED. THE EVENT WAS HAPPENED BEFORE THE LUMBAR FUSION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288387 ↗
• MalfunctionSep 17, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING IMPLANTATION OF THE TRIAL, THE THREADED DRIVER SNAPPED OFF, LEAVING THE BROKEN THREADED DRIVER STUCK INSIDE THE SCREW HOLE OF THE TRIAL AND UNABLE TO BE REMOVED. INCREASED FORCE WAS REQUIRED TO ADVANCE THE TRIAL INTO THE DISC SPACE, AND THERE WAS A LOSS OF CONTACT BETWEEN THE NAVIGATION DRIVER AND THE TRIAL. THE TRIAL AND NAVIGATION DRIVER WERE NO LONGER ABLE TO BE USED FOR THE DURATION OF THE SURGERY. TO REMOVE THE TRIAL FROM THE PATIENT, A SECOND DRIVER WAS USED TO MAKE CONTACT WITH THE ANGLED SCREW HOLE ON THE TRIAL, AND A SLAP HAMMER WAS THEN USED TO REMOVE THE TRIAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23071162 ↗
• MalfunctionSep 16, 2025Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE THREADED TIP OF THE INSERTER BROKE OFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062456 ↗
• MalfunctionAug 28, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE THREADED INSERTER SHAFT BROKE WHILE USING SLAP HAMMER TO BACK OUT A TRIAL. NO PATIENT INJURY AND WERE ABLE TO UNSCREW BROKEN SHAFT AND JUST USE ANOTHER INSERTER TO GET THE TRIAL OUT SAFELY. PROCEDURE PERFORMED WAS OBLIQUE LUMBAR INTERBODY FUSION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910934 ↗
• MalfunctionAug 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A MULTIPLE INSTRUMENTS. IT WAS REPORTED THAT THE ROD GRIPPER, WAS UNABLE TO HOLD THE ROD DUE TO A BROKEN INTERNAL TENSION MECHANISM. ADDITIONALLY, THE INSERTER WAS MISSING AN INTERNAL ENGAGEMENT SLEEVE. THE REDUCERS FAILED TO HOLD ONTO THE SCREW BECAUSE THE FOUR PRONGS THAT ENGAGE THE SCREW APPEARED TO BE WORN DOWN. FURTHERMORE, THE TIP OF THE SCREWDRIVER WAS BROKEN AT THE INTERFACE WITH THE SCREW. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22837992 ↗
• MalfunctionAug 7, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE BARREL THAT ATTACHES THE CAGE/TRIAL TO THE INSERTER HAD CAME APART. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22736102 ↗