LEVEL ONE CMF 25-882-07-91Recalls & reported problems
KLS-Martin L.P. · SCREW, MAXDRIVE, TLTS, TI-6AL-4V · Class 2 · Implant
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888118047854), received between Apr 13, 2017 and Jun 28, 2024 — classified as 8 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Osseointegration Problem4
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated2
- Break1
Patient problems
- Impaired Healing4
- Inadequate Osseointegration2
- Device Embedded In Tissue or Plaque1
- Unspecified Infection1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT SCREWS HAD BECOME LOOSENED FROM PATIENT'S COMPROMISED BONE. THEY WERE REMOVED.
Patient problems: Inadequate Osseointegration
MAUDE report 19632351 ↗InjuryJun 9, 2022Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT THE SCREWS BECAME LOOSE FROM THE PATIENT'S BONE. THEY WERE REMOVED.
Patient problems: Impaired Healing
MAUDE report 14648186 ↗InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem
IT WAS REPORTED THAT PRODUCT WAS REMOVED DUE TO COMING LOOSE.
Patient problems: Impaired Healing
MAUDE report 10553813 ↗InjuryFeb 7, 2020Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED A SCREW PULLED FROM THE BONE. ADDITIONAL TREATMENT IS EXPECTED ON AN UNKNOWN DATE.
Patient problems: Impaired Healing
MAUDE report 9683002 ↗InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED TO ADDRESS PATIENT INFECTION UNRELATED TO IMPLANT.
Patient problems: Unspecified Infection
MAUDE report 9460932 ↗InjuryJul 30, 2018Break; Break
IT WAS REPORTED THE HEAD OF A SCREW BROKE OFF. A PORTION OF THE SCREW REMAINS IN THE PATIENT'S BONE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7732796 ↗InjuryJul 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
InjuryApr 13, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT UNDERWENT A SCAPULAR FREE FLAP MANDIBLE RECONSTRUCTION ON (B)(6) 2017. THE DOCTOR REPORTED THE FLAP HEALED AND BONE WAS CONSOLIDATED HOWEVER SOME OF THE SCREWS WERE NO LONGER ENGAGED IN THE BONE. PATIENT UNDERWENT A SECONDARY SURGERY TO REMOVE THE HARDWARE.
Patient problems: Inadequate Osseointegration
MAUDE report 6489458 ↗
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
- LEVEL ONE CMF 50-797-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR13 reports
- DISTRACTION, INTERNAL 51-563-30-09KLS-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
- DISTRACTION, INTERNAL 51-526-30-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- NA 04.315.125Synthes GmbH · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.