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NA 04.500.250Recalls & reported problems

Synthes GmbH · 1.3MM CURVILINEAR DISTRACTOR R50/RIGHT · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587016887), received between Feb 10, 2020 and Oct 24, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Mechanical Problem1

Patient problems

  • Abscess1
  • Bone Fracture(s)1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THERE WERE BILATERAL MANDIBULAR OSTEOTOMIES, APPLICATION OF BILATERAL INTERNAL DISTRACTION DEVICES. LEFT SIDE ABSCESS (INFECTION). NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.3MM CURVILINEAR DISTRACTOR R50/RIGHT. THIS IS REPORT 1 OF 9 FOR (B)(4).

    Patient problems: Abscess

    MAUDE report 15657655 ↗
  • InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT HAD BILATERAL MANDIBULAR OSTEOTOMIES AND APPLICATION OF BILATERAL INTERNAL DISTRACTION DEVICES. POSTOPERATIVE COMPLICATION WAS THE RIGHT CORONOID FRACTURE HAD OCCURRED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 1.3MM CURVILINEAR DISTRACTOR R50/RIGHT. THIS IS REPORT 1 OF 9 FOR COMPLAINT (B)(4).

    Patient problems: Bone Fracture(s)

    MAUDE report 15655020 ↗
  • MalfunctionFeb 10, 2020Mechanical Problem; Mechanical Problem

    IT WAS REPORTED THAT ON (B)(6) 2019, THE IMPLANT DISTRACTION DEVICE DID NOT REALLY WORK LIKE IT WAS SUPPOSED TO. THERE WAS SOME PATIENT ERROR. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND THE OUTCOME ARE UNKNOWN. THIS IS REPORT 02 OF 04 OF (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9687045 ↗

Other EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices

All EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.