DISTRACTION, INTERNAL 51-405-42-09Recalls & reported problems
KLS-Martin L.P. · DIST, CRANIAL, MICRO ZURICH 2, END DRV, RTCH, 1.5-1.8 MM SCREW, TI-6AL-4V · Class 2 · Implant
All models of DISTRACTION, INTERNAL (67)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00888118080868), received between Apr 4, 2016 and Jan 28, 2021 — classified as 20 injuries.
The most frequently reported specific device problem is “Break” (11 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.
Most reported problems
Device problems
- Break11
- Fracture5
- Detachment Of Device Component2
- Device Operates Differently Than Expected1
- Improper or Incorrect Procedure or Method1
- Osseointegration Problem1
- Physical Resistance/Sticking1
Patient problems
- Impaired Healing9
- No Known Impact Or Consequence To Patient7
- No Consequences Or Impact To Patient2
- Fall1
- Inadequate Osseointegration1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED A DISTRACTOR BECAME BOUND. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 11248375 ↗InjuryMar 23, 2020Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED SCREWS BECAME LOOSE AND WERE REMOVED.
Patient problems: Impaired Healing
MAUDE report 9868033 ↗InjuryDec 19, 2019Break; Break
IT WAS REPORTED A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 9498395 ↗InjuryJul 2, 2019Break; Break
IT WAS REPORTED THE DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 8754440 ↗InjuryMay 13, 2019Break; Break
IT WAS REPORTED THAT A DISTRACTOR BROKE AND WAS REPLACED.
Patient problems: Impaired Healing
MAUDE report 8604917 ↗InjuryFeb 1, 2019Break; Break
IT WAS REPORTED THAT THE DISTRACTOR BROKE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8298213 ↗InjuryNov 16, 2018Break; Break
IT WAS REPORTED THAT THE DISTRACTOR BROKE DURING THE CONSOLIDATION PHASE. WILL REMAIN IMPLANTED UNTIL THE CONSOLIDATION PHASE IS COMPLETE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8077752 ↗InjuryOct 15, 2018Break; Break
IT WAS REPORTED THAT A DISTRACTOR BROKE. IT WAS REMOVED AND REPLACED.
Patient problems: Impaired Healing
MAUDE report 7966127 ↗InjuryFeb 15, 2018Break; Break
IT WAS REPORTED THE DISTRACTOR WAS FOUND IN THE PATIENT'S CRIB. NO REPORTED INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7272816 ↗InjuryFeb 15, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED THE DISTRACTOR WASN'T RATCHETING. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7272811 ↗InjuryDec 12, 2017Fracture; Fracture
ON (B)(6) 2017 PART OF THE RIGHT DISTRACTOR WAS FOUND BROKEN WITHIN THE PATIENT'S HEAD BANDAGE. PATIENT UNDERWENT AN ADDITIONAL SURGERY WHERE BOTH DISTRACTORS WERE REMOVED AND A DIFFERENT SURGICAL PROCEDURE WAS COMPLETED THAT DID NOT INVOLVE DISTRACTORS.
Patient problems: Impaired Healing
MAUDE report 7110444 ↗InjuryDec 12, 2017Fracture; Fracture
ON (B)(6) 2017 ITS WAS DISCOVERED PATIENT'S LEFT DISTRACTOR WAS BROKEN. PATIENT UNDERWENT ADDITIONAL SURGERY ON (B)(6) 2017 TO REMOVE AND REPLACE THE BROKEN DISTRACTOR.
Patient problems: Impaired Healing
MAUDE report 7110436 ↗InjuryOct 27, 2017Fracture; Fracture
PATIENT MADE CONTACT WITH A HARD SURFACE AND DISTRACTOR BROKE JUST PROXIMAL TO RATCHET BODY.
Patient problems: Impaired Healing
MAUDE report 6985072 ↗InjurySep 29, 2017Fracture; Fracture
TIP OF THE DISTRACTOR WHERE THE ACTIVATION ARM CONNECTS TO THE BODY BROKE DURING THE DISTRACTION PERIOD. PATIENT WAS BROUGHT BACK TO THE OR ON (B)(6) 2017 AND DISTRACTOR WAS REMOVED AND REPLACED WITH A NEW DISTRACTOR.
Patient problems: Inadequate Osseointegration
MAUDE report 6905760 ↗InjuryJun 19, 2017Fracture; Fracture
THE DEVICE BROKE DURING THE CONSOLIDATION PHASE. DOCTOR BELIEVES THE PATIENT ROLLED OVER THE END OF THE DISTRACTOR IN BED AND THE DEVICE BROKE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6652140 ↗InjuryMar 31, 2017Break
THE DISTRACTOR BROKE RIGHT WHERE THE CARDANIC EXTENSION CONNECTS TO THE DISTRACTOR. DISTRACTOR BODY IS STILL IMPLANTED IN THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6449187 ↗InjuryMar 2, 2017Break; Detachment Of Device Component
CRANIAL VAULT DISTRACTOR WAS IN ACTIVATION PHASE AT 2 MM PER DAY FOR 10 DAYS WHEN ONE DISTRACTOR "STOPPED CLICKING". IMPLANT WAS EVALUATED, CLEANED AND FELT TO BE WORKING. DISTRACTION CONTINUED FOR 3 MORE DAYS UNTIL PARENTS REPORTED THAT EXTERNAL ARM "BROKE OFF". DISTRACTOR WAS EVALUATED IN THE CLINIC AND FOUND TO BE BROKEN AT OR AROUND THE RATCHET MECHANISM. SURGEON BELIEVES THE PATIENT ROLLED ON HIS HEAD AND SNAPPED IT. PATIENT WAS BROUGHT TO THE OR FOR DEVICE REMOVAL AND REPLACEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6373169 ↗InjuryNov 7, 2016Improper or Incorrect Procedure or Method
A FEW DAYS POST-OP THE PATIENT WAS ROLLING HIS HEAD AROUND AND SNAGGED THE ACTIVATION ARM ON HIS BEDDING AND SNAPPED THE DISTRACTOR SPINDLE AT THE RATCHET MECHANISM DISABLING THE DISTRACTOR. THIS DEVICE IS THE REPLACEMENT DEVICE FROM A PREVIOUSLY REPORTED EVENT RECORDED ON MDR 9610905-2016-00040. DEVICE WAS SURGICALLY REMOVED ON (B)(6) 2016.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6082934 ↗InjuryJun 30, 2016Break; Detachment Of Device Component
TIP OF THE DISTRACTOR BROKE OFF AT WHERE THE ACTIVATION ARM WAS ATTACHED TO WHILE THE PATIENT ASLEEP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5762266 ↗InjuryApr 4, 2016Break
THE PATIENT FELL AND BROKE THE CRANIAL DISTRACTOR. A SECONDARY SURGERY WAS REQUIRED TO REPLACE THE DEVICE.
Patient problems: Fall
MAUDE report 5544529 ↗
Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices
- 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 51-526-30-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- NA 04.315.125Synthes GmbH · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- DISTRACTION, INTERNAL 51-401-91-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR10 reports
- LEVEL ONE CMF 50-795-26-09KLS-Martin L.P. · EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR9 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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