NA 21-20362Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · MMF SCREW, CROSS-PIN, SELF DRILLING · Class 2 · Implant
Data updated Oct 13, 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 07613154716302), received between Sep 13, 2023 and Sep 13, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
- Migration1
Patient problems
- Discomfort1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2023Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration
IT WAS REPORTED THAT THE CUSTOMER FOUND THE MMF SCREWS WERE LOOSE AS IF THEY ERE NOT HOLDING IN PLACE. IT IS NOT KNOWN AT THIS TIME IF THERE WILL BE OR HAS BEEN A REVISION SURGERY TO FIX THE LOOSE SCREWS. NO OTHER INFORMATION IS KNOWN AT THIS TIME.
Patient problems: Discomfort
MAUDE report 17740759 ↗
Other SCREW, FIXATION, INTRAOSSEOUS devices
- MatrixMIDFACE 04.503.226.01Synthes GmbH · SCREW, FIXATION, INTRAOSSEOUS21 reports
- NA 400.736ESynthes GmbH · SCREW, FIXATION, INTRAOSSEOUS21 reports
- OsteoMed 204-1206Osteomed LLC · SCREW, FIXATION, INTRAOSSEOUS14 reports
- NA 201.928Synthes GmbH · SCREW, FIXATION, INTRAOSSEOUS14 reports
- LEVEL ONE CMF 25-092-12-91KLS-Martin L.P. · SCREW, FIXATION, INTRAOSSEOUS11 reports
- OsteoMed 202-2016Osteomed LLC · SCREW, FIXATION, INTRAOSSEOUS9 reports
- LEVEL ONE CMF 25-092-08-91KLS-Martin L.P. · SCREW, FIXATION, INTRAOSSEOUS9 reports
- MatrixMIDFACE 04.503.204.01Synthes GmbH · SCREW, FIXATION, INTRAOSSEOUS8 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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