Spine Instruments 03.51.10.0600Recalls & reported problems
Medacta International SA · Lenke Probe - square tip - Straight · Class 1
All models of Spine Instruments (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630971266797), received between Mar 28, 2025 and Mar 28, 2025 — classified as 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
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 28, 2025Fracture; Fracture
DURING L1-S2-SI SURGERY, THE SURGEON MALLETED THE LEKE PROBE IN RIGHT L2 AND THE TIP OF THE DEVICE BROKE IN THE PEDICLE. A TREPHINE ALONG WITH A PAIR OF VICE GRIPS WAS UTILIZED TO REMOVE THE BROKEN TIP. BONE QUALITY WAS REPORTED NOT BEING SCLEROTIC BUT ISSUE IN ADVANCING THE GEAR SHIFT THAT REQUIRED MALLETING. SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES OF DELAY ON 4 HOURS OF SURGERY. 7.0MM (DIAMETER) X55MM (LENGTH) SCREW WAS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21718316 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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