NA 400.812Recalls & reported problems
Synthes GmbH · 1.5MM TI CORTEX SCREW SELF-TAPPING 12MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982203731), received between Jul 28, 2021 and Jul 30, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break3
- Entrapment of Device2
Patient problems
- Foreign Body In Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2025Break; Entrapment of Device; Break; Entrapment of Device
ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGERY HAS BEEN COMPLETED SUCCESSFULLY AND IT WAS EXTENDED BY A FEW MINUTES.
Patient problems: Foreign Body In Patient
MAUDE report 22664164 ↗MalfunctionJul 30, 2025Break; Entrapment of Device; Break; Entrapment of Device
ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGERY HAS BEEN COMPLETED SUCCESSFULLY AND IT WAS EXTENDED BY A FEW MINUTES.
Patient problems: Foreign Body In Patient
MAUDE report 22664163 ↗MalfunctionJul 28, 2021Break; Break
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS. PATIENT¿S DEMOGRAPHICS WERE PROVIDED FOR SOME OF THE EVENTS AS FOLLOWS: PATIENT¿S AGE RANGE UNKNOWN YEARS OLD. PATIENT¿S WEIGHT RANGE ¿ UNKNOWN POUNDS. GENDER ¿ 0 FEMALE, 0 MALE, AND 1 UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 12242628 ↗
Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices
- DISTRACTION, INTERNAL 51-405-42-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR20 reports
- LEVEL ONE CMF 50-760-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR18 reports
- DISTRACTION, INTERNAL 51-563-30-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR13 reports
- LEVEL ONE CMF 50-797-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR13 reports
- LEVEL ONE CMF 50-777-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR11 reports
- DISTRACTION, INTERNAL 51-401-91-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- NA 04.315.125Synthes GmbH · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- DISTRACTION, INTERNAL 51-526-30-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 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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