NextAR Spine Platform 03.57.10.0026Recalls & reported problems
Medacta International SA · NextAR Spine Double Short Clamp 25° · Class 2
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 07630971292499), received between Feb 6, 2024 and Apr 11, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Mechanical Jam1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bone Fracture(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2024Fracture; Fracture
THE FIXATION SCREW OF THE NEXTAR SPINE DOUBLE SHORT CLAMP 25° WAS BROKEN AND IT WAS NOT POSSIBLE TO REMOVE THE CLAMP AT THE END OF THE SURGERY. IT HAS BEEN NECESSARY TO BREAK THE SPINOUS PROCESS IN ORDER TO REMOVE THE INSTRUMENT. THE DELAY TIME WAS 30/40 MINUTE AND THE TOTAL TIME OF THE SURGERY WAS 4H.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19085957 ↗InjuryFeb 6, 2024Mechanical Jam; Mechanical Jam
DURING NEXTAR SPINE SURGERY, AFTER 4 K-WIRES (USED FOR PEDICLE SCREW INSERTION GUIDE) HAVE BEEN POSITIONED, THE NEXTAR SPINE DOUBLE SHORT CLAMP 25° WAS NOT STABLE ANYMORE ON THE BONE AND SOME MOVEMENTS OF IT HAVE BEEN DETECTED. WHEN THE SURGEON TRIED TO REPOSITION THE CLAMP, IT WAS NOT POSSIBLE TO MOUNT IT NEWLY ON THE PATIENT'S BONE. THE SCREW OF THE CLAMP WAS BLOCKED. THEREFORE, THE SURGEON POSITIONED THE LONG CLAMP 25° (ALTERNATIVE INSTRUMENT) ON THE SAME PROCESSUS SPINOUS TO INSERT 2 ADDITIONAL K-WIRES AND IN THAT MOMENT, A FRACTURE OF THE PROCESSUS SPINOUS HAS BEEN DETECTED IN TH5/TH6. THE PATIENT'S BONE QUALITY WAS POOR AND SEVERELY OSTEOPOROTIC. THE CONVENTIONAL INSTRUMENTATION WAS USED TO REPOSITION THE 2 K-WIRES AND FINISH THE SURGERY. THE SURGEON DECIDED TO NOT FIX THE FRACTURE AND TO CLOSE THE PATIENT. DELAY TIME IS APPROXIMATELY 15 MINUTES.
Patient problems: Bone Fracture(s)
MAUDE report 18648847 ↗
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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 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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