DISTRACTION, INTERNAL, STERILE 51-563-30-71Recalls & reported problems
KLS-Martin L.P. · DIST, CRANIAL, ZURICH 2, END DRV, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V · Class 2 · Implant
All models of DISTRACTION, INTERNAL, STERILE (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888118114471), received between Jun 15, 2021 and Jun 3, 2024 — classified as 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Activation Problem” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Problem2
- Adverse Event Without Identified Device or Use Problem1
- Device Appears to Trigger Rejection1
- Device-Device Incompatibility1
- Failure to Advance1
- Insufficient Device Problem Information1
- Thermal Decomposition of Device1
Patient problems
- Impaired Healing3
- Caustic/Chemical Burns1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Skin Tears1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 ↗InjuryNov 23, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT A DISTRACTOR FOOTPLATE LOST FIXATION DUE TO AN OFF-LABEL USE.
Patient problems: Impaired Healing
MAUDE report 15852892 ↗MalfunctionNov 22, 2022Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS OBSERVED TO HAVE HAD PLASTIC HAS BURN MARKS AT BASE OF INSTRUMENT TIPS. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE REPORTER WAS UNSURE IF THE REPORTED ISSUE WAS ALSO IDENTIFIED DURING THE PROCEDURE, BUT CENTRAL PROCESSING REPORTED THE THERMAL DAMAGE. NO PATIENT INFORMATION DEMOGRAPHIC INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15847434 ↗InjuryJun 15, 2021Activation Problem; Activation Problem
IT WAS REPORTED A DISTRACTOR WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 11999687 ↗
Other Cranial Distraction System devices
- DISTRACTION, INTERNAL, STERILE 51-405-42-71KLS-Martin L.P. · Cranial Distraction System6 reports
- DISTRACTION, INTERNAL, STERILE 25-025-12-71KLS-Martin L.P. · Cranial Distraction System1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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