DISTRACTION, INTERNALRecalls & reported problems across all models
KLS-Martin L.P. · 67 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 180
- Deaths reported
- 0
- Injuries reported
- 166
- Recalls
- 0
We found 67 models of DISTRACTION, INTERNAL by KLS-Martin L.P. in the FDA's device registry (GUDID). Together they are named in 180 adverse event reports in the FDA's MAUDE database, received between Apr 4, 2016 and Apr 23, 2026 — classified as 166 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Break” (92 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported DISTRACTION, INTERNAL problems
Device problems
- Break92
- Adverse Event Without Identified Device or Use Problem20
- Fracture17
- Detachment Of Device Component11
- Osseointegration Problem11
- Detachment of Device or Device Component8
- Improper or Incorrect Procedure or Method4
- Migration or Expulsion of Device4
Patient problems
- Impaired Healing98
- No Known Impact Or Consequence To Patient25
- No Consequences Or Impact To Patient17
- Insufficient Information13
- Inadequate Osseointegration9
- No Code Available4
- Device Embedded In Tissue or Plaque3
- Fall3
DISTRACTION, INTERNAL models
67 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DISTRACTION, INTERNAL 51-405-42-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR20 reports
- DISTRACTION, INTERNAL 51-563-30-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR13 reports
- DISTRACTION, INTERNAL 51-401-91-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- DISTRACTION, INTERNAL 51-526-30-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- DISTRACTION, INTERNAL 51-361-30-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR7 reports
- DISTRACTION, INTERNAL 51-424-30-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR7 reports
- DISTRACTION, INTERNAL 50-347-07-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR6 reports
- DISTRACTION, INTERNAL 51-410-33-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR5 reports
- DISTRACTION, INTERNAL 51-424-20-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR5 reports
- DISTRACTION, INTERNAL 51-509-15-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR5 reports
- DISTRACTION, INTERNAL 51-605-30-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR4 reports
- DISTRACTION, INTERNAL 50-347-07-61EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR4 reports
- DISTRACTION, INTERNAL 50-347-09-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR3 reports
- DISTRACTION, INTERNAL 50-348-05-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR3 reports
- DISTRACTION, INTERNAL 51-360-30-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR3 reports
- DISTRACTION, INTERNAL 51-402-16-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR3 reports
- DISTRACTION, INTERNAL 51-424-21-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR3 reports
- DISTRACTION, INTERNAL 51-564-30-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR3 reports
- DISTRACTION, INTERNAL 51-643-50-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR3 reports
- DISTRACTION, INTERNAL 50-347-05-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL 50-348-09-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL 51-350-30-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL 51-421-20-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL 51-423-20-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL 51-423-30-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL 51-424-25-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL 51-426-30-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL 51-429-30-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL 51-556-15-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL 51-556-20-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL 51-557-15-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL 51-557-20-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL 51-508-15-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL 51-509-10-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL 26-706-23-09COMPONENT, TRACTION, INVASIVE1 report
- DISTRACTION, INTERNAL 51-400-30-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-401-20-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-401-50-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-405-40-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-410-43-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-413-30-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-423-25-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-426-25-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-430-95-07SCREWDRIVER1 report
- DISTRACTION, INTERNAL 51-432-25-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-524-09-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-524-15-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-525-15-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-540-25-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-541-30-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-555-13-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-651-20-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 99-472-33-01EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-563-40-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 99-060-78-02EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 99-473-40-01EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-565-09-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 99-473-39-02EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-567-18-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-567-09-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 50-347-05-61EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 99-461-66-01EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-443-30-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-360-40-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-406-33-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-351-22-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL 51-402-73-09EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
Recent DISTRACTION, INTERNAL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 23, 2026Difficult to Advance
IT WAS REPORTED THAT A CRANIAL DISTRACTOR WAS NOT ADVANCING AS EXPECTED. IT WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 24972615 ↗InjuryFeb 27, 2026Fracture
IT WAS REPORTED AN ACTIVATION ARM BECAME FRACTURED FROM THE DISTRACTOR FOLLOWING APPROXIMATELY 6 WEEKS OF IMPLANTATION. THE ACTIVATION ARM WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 24469116 ↗InjuryFeb 10, 2026Misassembly by Users
IT WAS REPORTED THE REMOTE DETACH ARM ON THE RIGHT-SIDE DISTRACTOR WAS SECURED IN PLACE.
Patient problems: Insufficient Information
MAUDE report 24307830 ↗InjuryNov 18, 2025Difficult to Advance; Difficult to Advance
PALATAL DISTRACTOR WAS NOT ADVANCING AS EXPECTED AFTER PROBLEMATIC OSTEOTOMY. PATIENT WAS RE-OSTEOTOMIZED AND DISTRACTOR WAS REPLACED. REPLACEMENT DEVICE EXPANDED CORRECTLY WITH BONE RE-OSTEOTOMIZED.
Patient problems: Insufficient Information
MAUDE report 23583248 ↗InjuryOct 29, 2025Fracture; Fracture
IT WAS REPORTED THE DISTRACTOR FRACTURED DURING THE DISTRACTION PHASE. IT WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 23412890 ↗InjuryOct 24, 2025Activation Problem; Activation Problem
IT WAS REPORTED THE ACTIVATION ARM BECAME DETACHED FROM THE DISTRACTOR. IT WAS REMOVED.
Patient problems: Insufficient Information
MAUDE report 23380120 ↗InjurySep 12, 2025Activation Problem; Activation Problem
IT WAS REPORTED THE DISTRACTOR BECAME FRACTURED DURING THE DISTRACTION PHASE. IT WAS REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 23037855 ↗InjuryJun 20, 2025Fracture; Fracture
IT WAS REPORTED THAT A DISTRACTOR BECAME FRACTURED DURING USE. IT WAS REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22297058 ↗InjuryJun 12, 2025Fracture; Fracture
IT WAS REPORTED THAT A DISTRACTOR BECAME FRACTURED FOLLOWING 15 DAYS OF IMPLANTATION. IT WAS REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22193871 ↗InjuryMay 30, 2025Difficult to Advance; Difficult to Advance
IT WAS REPORTED DISTRACTORS WERE NOT TURNING AS EXPECTED. THEY WERE REMOVED AND REPLACED.
Patient problems: Insufficient Information
MAUDE report 22118255 ↗InjuryMay 2, 2025Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED DISTRACTOR SCREWS BECAME LOOSE FROM COMPROMISED BONE DURING DISTRACTION. THEY WERE REMOVED AND REPLACED.
Patient problems: Inadequate Osseointegration
MAUDE report 21950210 ↗InjuryOct 31, 2024Loss of Osseointegration; Loss of Osseointegration
PHYSICIAN REPORTED A DISTRACTOR SCREW BECAME LOOSE FROM PATIENT'S BONE DUE TO POOR BONE QUALITY. PHYSICIAN SPECIFICALLY NOTED DEVICE DID NOT FAIL OR HAVE ANY ISSUES. DEVICE WAS REMOVED AND REPLACED.
Patient problems: Inadequate Osseointegration
MAUDE report 20577387 ↗InjuryAug 15, 2024Break; Break
IT WAS REPORTED A DISTRACTOR BROKE DUE TO UNKNOWN REASONS. IT WAS REMOVED AND REPLACED PRIOR TO THE CONSOLIDATION PHASE.
Patient problems: Impaired Healing
MAUDE report 19996202 ↗InjuryJul 25, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A DISTRACTOR BROKE DUE TO UNKNOWN REASONS. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 19825763 ↗InjuryFeb 21, 2024Break; Break
IT WAS REPORTED A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 18748205 ↗
Other KLS-Martin L.P. products
- LEVEL ONE CMF150 models · 434 reports
- LEVEL ONE36 models · 205 reports
- LEVEL ONE THORACIC, STERILE30 models · 166 reports
- LEVEL ONE THORACIC20 models · 78 reports
- IPS29 models · 69 reports
- LEVEL ONE NEURO27 models · 63 reports
- DISTRACTION, INTERNAL, STERILE22 models · 47 reports
- LEVEL ONE ORTHOANCHOR15 models · 20 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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