Spine Instruments 03.51.10.0490Recalls & reported problems
Medacta International SA · Reduction device - Short Acorn Reamer Ø6.5 L195 · Class 1
All models of Spine Instruments (28)
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 07630971251304), received between Apr 30, 2024 and May 2, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (2 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.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 2, 2024Fracture; Fracture
DURING A SPINE SURGERY PERFORMED FOR SCOLIOSIS CORRECTION, ONE OF THE TEETH OF TWO REDUCTION DEVICES BROKE WHILE EXECUTING THE CORRECTION.THESE METAL FRAGMENTS FROM BOTH THE INSTRUMENTS REMAINED IN THE PATIENT AND ARE VISIBLE FROM THE X-RAYS. THE SURGERY WAS ANYWAY COMPLETED SUCCESSFULLY USING BACK UP INSTRUMENTS AND NO DELAY HAS BEEN REPORTED. TOTAL TIME OF THE SURGERY WAS APPROXIMATELY 3 HOURS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19228465 ↗InjuryApr 30, 2024Fracture; Fracture
DURING A SPINE SURGERY PERFORMED FOR SCOLIOSIS CORRECTION, ONE OF THE TEETH OF SIX REDUCTION DEVICES BROKE WHILE EXECUTING THE CORRECTION. THE SURGERY WAS ANYWAY COMPLETED SUCCESSFULLY USING BACK UP INSTRUMENTS AND NO DELAY HAS BEEN REPORTED. TOTAL TIME OF THE SURGERY WAS APPROXIMATELY 2 HOURS AND 30 MINUTES.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19211478 ↗
Other Orthopedic Manual Surgical Instrument devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- 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
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- 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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