LACTOSORB® SYSTEM 915-2451Recalls & reported problems
Biomet Microfixation, Inc · Class 1
All models of LACTOSORB SYSTEM (7)
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 00841036055714), received between Sep 14, 2020 and Sep 14, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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.
Most reported problems
Device problems
- Device-Device Incompatibility4
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT MULTIPLE BLADES WERE UNABLE TO RETAIN SCREWS DURING A SURGICAL PROCEDURE. THE FIVE (5) MM SCREWS COULD BE GRASPED AND THE SEVEN (7) MM SCREWS COULD NOT BE GRASPED. THE PROCEDURE WAS COMPLETED WITH ALTERNATE BLADES. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10529187 ↗MalfunctionSep 14, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT MULTIPLE BLADES WERE UNABLE TO RETAIN SCREWS DURING A SURGICAL PROCEDURE. THE FIVE (5) MM SCREWS COULD BE GRASPED, AND THE SEVEN (7) MM SCREWS COULD NOT BE GRASPED. THE PROCEDURE WAS COMPLETED WITH ALTERNATE BLADES. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10529117 ↗MalfunctionSep 14, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT MULTIPLE BLADES WERE UNABLE TO RETAIN SCREWS DURING A SURGICAL PROCEDURE. THE FIVE (5) MM SCREWS COULD BE GRASPED AND THE SEVEN (7) MM SCREWS COULD NOT BE GRASPED. THE PROCEDURE WAS COMPLETED WITH ALTERNATE BLADES. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10529111 ↗MalfunctionSep 14, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE BLADE COULD NOT RETAIN SCREWS. FIVE (5) MM SCREWS COULD BE GRASPED AND SEVEN (7) MM SCREWS COULD NOT BE GRASPED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE BLADE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10528450 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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.
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