N/A 693.601Recalls & reported problems
Globus Medical, Inc. · Lateral Inserter · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889095058468), received between Mar 4, 2024 and Oct 2, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Detachment of Device or Device Component1
Patient problems
- Failure of Implant2
- Bone Fracture(s)1
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 2, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY THE TIP OF THE LATERAL INSERTER WAS BROKEN AND LEFT IN THE CAGE POST OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 20354127 ↗MalfunctionMar 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
DURING SURGERY THE PATIENT'S RETROPERITONEUM WAS DAMAGED WHILE BEING ROLLED BETWEEN TWO INSTRUMENTS. THIS EVENT OCCURRED IN JAPAN.
Patient problems: Bone Fracture(s)
MAUDE report 18837896 ↗MalfunctionMar 4, 2024Fracture; Fracture
THE TIP OF THE LATERAL INSERTER BROKE OFF IN THE IMPLANT DURING INSERTION. THE SURGEON DID NOT REMOVE THE BROKEN TIP AS IT WAS FLUSH WITH THE IMPLANT AND IT REMAINS IN THE PATIENT.
Patient problems: Failure of Implant
MAUDE report 18826454 ↗MalfunctionMar 4, 2024Fracture; Fracture
THE TIP OF THE LATERAL INSERTER BROKE OFF IN THE RISE-L IMPLANT. THE SURGEON WAS UNABLE TO REMOVE THE BROKEN TIP AND IT REMAINS IN THE PATIENT.
Patient problems: Failure of Implant
MAUDE report 18825777 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page