DISTRACTION, INTERNAL, STERILERecalls & reported problems across all models
KLS-Martin L.P. · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls
- 0
We found 22 models of DISTRACTION, INTERNAL, STERILE by KLS-Martin L.P. in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Oct 15, 2018 and Feb 26, 2025 — classified as 45 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (21 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, STERILE problems
Device problems
- Break21
- Adverse Event Without Identified Device or Use Problem12
- Activation Problem3
- Installation-Related Problem2
- Material Separation2
- Use of Device Problem2
- Activation Failure1
- Device Appears to Trigger Rejection1
Patient problems
- Impaired Healing33
- No Clinical Signs, Symptoms or Conditions5
- Injury3
- Insufficient Information3
- Caustic/Chemical Burns1
- No Known Impact Or Consequence To Patient1
- Skin Tears1
DISTRACTION, INTERNAL, STERILE models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DISTRACTION, INTERNAL, STERILE 51-563-30-71Cranial Distraction System7 reports
- DISTRACTION, INTERNAL, STERILE 51-405-42-71Cranial Distraction System6 reports
- DISTRACTION, INTERNAL, STERILE 51-556-20-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR4 reports
- DISTRACTION, INTERNAL, STERILE 51-424-25-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR3 reports
- DISTRACTION, INTERNAL, STERILE 51-429-30-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR3 reports
- DISTRACTION, INTERNAL, STERILE 51-440-30-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR3 reports
- DISTRACTION, INTERNAL, STERILE 51-360-30-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL, STERILE 51-361-30-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL, STERILE 51-401-91-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL, STERILE 51-424-20-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL, STERILE 51-557-20-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR2 reports
- DISTRACTION, INTERNAL, STERILE 50-347-07-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL, STERILE 51-401-25-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL, STERILE 51-424-30-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL, STERILE 51-432-25-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL, STERILE 51-526-30-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL, STERILE 51-528-30-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL, STERILE 51-541-30-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL, STERILE 51-567-18-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL, STERILE 51-424-31-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL, STERILE 51-410-23-71EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR1 report
- DISTRACTION, INTERNAL, STERILE 25-025-12-71Cranial Distraction System1 report
Recent DISTRACTION, INTERNAL, STERILE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
DURING DISTRACTION SURGEON OBSERVED THAT PATIENT ANATOMY LIFTED UP POSTERIORLY MORE THAN SURGEON HAD INTENDED. SURGEON ELECTED TO REMOVE DEVICE AND NOT REPLACE IT.
Patient problems: Insufficient Information
MAUDE report 21468512 ↗InjuryFeb 12, 2025Material Separation; Material Separation
IT WAS REPORTED A DISTRACTOR BROKE AFTER ACHIEVING DISTRACTION. IT WAS REMOVED AND REPLACED FOR CONSOLIDATION PURPOSES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21369653 ↗InjuryFeb 12, 2025Material Separation; Material Separation
IT WAS REPORTED A DISTRACTOR BROKE AFTER ACHIEVING DISTRACTION. IT WAS REMOVED AND REPLACED FOR CONSOLIDATION PURPOSES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21369640 ↗InjuryJun 3, 2024Activation Problem; Activation Problem
IT WAS REPORTED THE DISTRACTOR WAS NOT ADVANCING AS EXPECTED. IT WAS REMOVED.
Patient problems: Insufficient Information
MAUDE report 19447552 ↗InjuryApr 16, 2024Break; Break
IT WAS REPORTED WHEN THE DISTRACTOR WAS ACTIVATED THE CARDANIC EXTENSION BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 19116154 ↗InjuryMar 28, 2024Break; Break
IT WAS REPORTED A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 18990985 ↗InjuryMar 8, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
ACCORDING TO THE EXPLANTATION REPORT FORM, THE USER HAD A LARGE SKIN DEFECT. THERE WAS AN INFECTION REPORTED WITH STAPHYLOCOCCUS AUREUS. THE DEVICE WAS EXPLANTED.
Patient problems: Skin Tears
MAUDE report 18864562 ↗InjuryOct 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6), 2023, WE HAVE BEEN INFORMED ABOUT TWO INCIDENT WITH ECG ELECTRODES AT A HOSPITAL, IN LUXEMBOURG. SKINTACT ELECTRODES MODEL T-VO01, LOT NUMBER 230517-0246 HAVE BEEN USED. THE COMPLAINANT REPORTED "I HAVE RECEIVED A COMPLAINT FOR ELECTRODES SKINTACT TVO01. TWO PATIENTS HAVE BEEN BURN AFTER THOSE ELECTRODES REMAIN ON THEIR SKIN DURING A 24H HOLTER MONITORING. PATIENTS DO NOT HAVE ANY KNOWN ALLERGY AND AS PER THE DOCTOR IT COULD BE CHEMICAL BURN." THE INITIAL REPORT CONTAINED ALSO A PICTURE SHOWING THE PATIENT INJURY. THE RESOLUTION OF THE PICTURE IS LOW BUT IT IS VISIBLE THAT 4 ECG ELECTRODES HAD BEEN APPLIED TO THE PATIENT AND UNDERNEATH TWO OF THE 4 ATTACHED ECG ELECTRODES A SKIN INJURY HAD HAPPENED VISIBLE ON THE PICTURE. ON (B)(6), 2023 WE HAVE RECEIVED A FILLED QUESTIONNAIRE FOR BOTH INVOLVED PATIENTS AND PICTURES WITH A HIGH RESOLUTION SHOWING THE INJURIES. IT WAS STATED THAT A 24 HOURS HOLTER WAS PERFORMED ON BOTH PATIENTS. AN UNKNOWN MONITOR AND 7 SKINTACT ECG ELECTRODES MODEL TVO01 HAVE BEEN USED PER PATIENT. PATIENT A: WAS DESCRIBED AS 11 YEAR OLD MALE PATIENT NORMAL BODY TYPE, CAUCASIAN AND NORMAL SKIN. THE GENERAL STATE OF THE PATIENT WAS NORMAL. THE SKIN PREPAR
Patient problems: Caustic/Chemical Burns
MAUDE report 17983229 ↗InjuryJul 31, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 17430564 ↗InjuryJul 31, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A CARDANIC EXTENSION BROKE DUE TO THE PATIENTS' FRANTIC MOVEMENTS. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 17430563 ↗InjuryJul 31, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 17430562 ↗InjuryApr 27, 2023Installation-Related Problem; Installation-Related Problem
UPON ACTIVATION, DISTRACTOR FOOTPLATE WAS OBSERVED TO BE BENDING ON CT SCAN DUE TO INCOMPLETE INSTALLATION PROCEDURE. IT WAS REMOVED AND REPLACED AND NEW DISTRACTOR PERFORMED AS EXPECTED.
Patient problems: Impaired Healing
MAUDE report 16824401 ↗InjuryApr 27, 2023Installation-Related Problem; Installation-Related Problem
UPON ACTIVATION, DISTRACTOR FOOTPLATE WAS OBSERVED TO BE BENDING ON CT SCAN DUE TO INCOMPLETE INSTALLATION PROCEDURE. IT WAS REMOVED AND REPLACED AND NEW DISTRACTOR PERFORMED AS EXPECTED.
Patient problems: Impaired Healing
MAUDE report 16824391 ↗InjuryMar 13, 2023Break; Break
IT WAS REPORTED A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 16530949 ↗InjuryFeb 14, 2023Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A DISTRACTOR WOULD NOT ADVANCE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 16375234 ↗
Other KLS-Martin L.P. products
- LEVEL ONE CMF150 models · 434 reports
- LEVEL ONE36 models · 205 reports
- DISTRACTION, INTERNAL67 models · 180 reports
- LEVEL ONE THORACIC, STERILE30 models · 166 reports
- LEVEL ONE THORACIC20 models · 78 reports
- IPS29 models · 69 reports
- LEVEL ONE NEURO27 models · 63 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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