MectaLIF 03.26.256Recalls & reported problems
Medacta International SA · MectaLIF Oblique TiPEEK 10x24x10 L5° · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630971290587), received between Jun 25, 2024 and Aug 29, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Osseointegration Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Inadequate Osseointegration1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem
AT 1 MONTH AND A HALF FROM PRIMARY SPINE SURGERY, DURING A POST-OP VISIT, THE SURGEON OBSERVED THAT THE 10X24X10 L5° OBLIQUE CAGE HAD MIGRATED OUT OF THE L4-L5 DISC SPACE. THE PATIENT'S BONE QUALITY SHOWS SIGNS OF OSTEOPENIA. A UNILATERAL APPROACH WAS USED, COMPRESSION WAS APPLIED AFTER CAGE INSERTION, SHAVERS WERE USED, NOT TRIALS. THE PATIENT IS NOT REPORTING PAIN AND HAS REFUSED A REVISION SURGERY AT THIS TIME.
Patient problems: Inadequate Osseointegration
MAUDE report 22920622 ↗InjuryJun 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
AT 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND THERE WAS A NON-UNION OF THE VERTEBRAS. THE SURGEON REMOVED ALL COMPONENTS EXCEPT THE Ø7X45 PEDICLE SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE BONE WAS OSTEOPOROTIC AND THE PATIENT WAS OVERALL UNHEALTHY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19605509 ↗
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- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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