MectaLIF Anterior System 03.30.133Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030875434), received between Jun 8, 2018 and Dec 16, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2022Fracture; Fracture

  THE SURGEON NOTED AFTER SURGERY THAT THE S1 SCREW HAD BROKEN. THE SURGEON THERE WAS NOT A COMPLETE FUSION ACROSS THE CAGE AND EVENTUALLY DECIDED TO FURTHER STABILIZE THE PATIENT WITH POSTERIOR FIXATION, ABOUT 3 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 15994328 ↗
• MalfunctionSep 3, 2019Fracture; Fracture

  THE PATIENT CAME IN FOR A POST-OP X-RAY 2 MONTHS AND 10 DAYS AFTER PRIMARY AND IT WAS OBSERVED THAT AN ALIF SCREW HAD FRACTURED. THE REASON FOR THE SCREW FRACTURE IS UNKNOWN. THE SURGEON DOES NOT PLAN ON REVISING THE PATIENT AT THIS TIME, BUT WILL MONITOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8955164 ↗
• MalfunctionSep 2, 2019Break; Fracture; Break; Fracture

  THE PATIENT CAME IN FOR A POST-OP X-RAY 5 MONTHS AND 2 DAYS AFTER PRIMARY AND IT WAS OBSERVED THAT AN ALIF SCREW HAD FRACTURED. THE REASON FOR THE SCREW FRACTURE IS UNKNOWN. THE SURGEON DOES NOT PLAN ON REVISING THE PATIENT AT THIS TIME, BUT WILL MONITOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8953780 ↗
• MalfunctionSep 2, 2019Break; Break

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A SCREW FRACTURE. DURING THE PRIMARY SPINE SURGERY, A LARGE ANTERIOR OSTEOPHYTE WAS PRESENT AND IMPEDED THE CAGE TO BE PLACED ALL THE WAY POSTERIOR TOWARDS THE BACK OF THE VERTEBRAL BODY. THE IMPLANT WAS PROUD ANTERIORLY AND NOT IN AN IDEAL POSITION. THE PATIENT WAS ALSO FRACTURED IN THE ANTERIOR SUPERIOR CORNER OF S1. THE PATIENT DID NOT SUSTAIN ANY ADDITIONAL SUBSIDENCE OR INSTABILITY. THE SURGEON DOES NOT PLAN ON REVISING THE PATIENT AT THIS TIME, BUT WILL MONITOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8953728 ↗
• MalfunctionJul 5, 2019Break; Break

  SPINE SCREW BREAKAGE AFTER ABOUT 1 YEAR AND 7 MONTHS FROM PRIMARY SURGERY. NO EVIDENCE OF REVISION SURGERY PERFORMED FOR THE MOMENT. THE PATIENT HAD A REVISION SURGERY FEW DAYS AFTER PRIMARY TO PUT L5 ENDPLATE AND TO SHORTEN S1 SCREW SITTING IN THE FORAMEN, THE SURGEON ONLY SWAPPED OUT 1 SCREW AS HE WAS UNHAPPY WITH SIZE HE ORIGINALLY USED. THE PRIMARY SURGERY HAS BEEN PERFORMED ON THE (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8764337 ↗
• MalfunctionJun 8, 2018Break; Break

  DURING THE FINAL TIGHTENING TWO SCREW HEADS BROKE. THE PATIENT HAS VERY SCLEROTIC BONE AND THE SURGEON DIDN'T USE THE TORQUE LIMITER BECAUSE HE NEEDED AN HIGHER TORQUE. THE SCREWS WERE LEAVED IN THE PATIENT AND THE SCREW HEADS RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7582498 ↗