Mectalif Oblique 03.26.045Recalls & reported problems
Medacta International SA · Oblique Interbody Fusion Device 12x28x10 L5° · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030830648), received between Dec 21, 2018 and Feb 29, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Deformation1
- Migration or Expulsion of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 29, 2024Material Deformation; Material Deformation
SURGERY WAS PERFORMED AT L4-L5. AFTER INSERTING THE MECTALIF OBLIQUE (TI PEEK) CAGE, WHEN THE SURGEON WAS TRYING TO ADJUST THE POSITION BY USING THE FINAL IMPACTOR (REF03.22.10.0263), HE DISCOVERED THAT THE THREAD OF THE CAGE WAS DAMAGED. THE REMOVER COULD NOT BE CONNECTED WITH THE CAGE ANYMORE. COMPETITOR'S INSTRUMENT WERE USED TO REMOVE THE DAMAGED CAGE AND A NEW CAGE WAS IMPLANTED. DELAY TIME 1 HOUR (TOTAL TIME OF THE SURGERY 5 HOURS).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18807331 ↗InjuryDec 21, 2018Migration or Expulsion of Device
TLIF SURGERY PERFORMED AT L4-L6 WITH MYSPINE MC GUIDE ON (B)(6) 2018. AT THAT TIME THE SURGEON FELT THE PEDICLE SCREWS MIGHT BE LOOSENED DURING COMPRESSION AT L5-L6, SO IN ORDER TO STRENGTHEN THE FIXATION, THE SURGEON USED TOTAL 2 CROSS CONNECTORS. THE PATIENT ALLEGED PAIN ABOUT 2 WEEKS LATER AFTER THE PRIMARY SURGERY. THE SURGEON DISCOVERED THE MECTALIF OBLIQUE CAGE IMPLANTED AT L5-L6 WAS MIGRATED TO POSTERIOR SIDE IN THE X-RAY. REVISION SURGERY PERFORMED ON (B)(6)(1 MONTH AND A HALF AFTER PRIMARY SURGERY), AT THAT TIME THE SURGEON REPLACED THE PEDICLE SCREW WITH NEW ONE AND IMPACTED THE SAME MECTALIF OBLIQUE CAGE INTO THE INTERVERTEBRAL DISC SPACE AGAIN.
Patient problems: Pain
MAUDE report 8188869 ↗
Other Intervertebral Fusion Device With Bone Graft, Lumbar devices
- T-PAL 03.812.003Synthes GmbH · Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- 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
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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