Typenex Medical NV0635Recalls & reported problems
Weinert Fiber Optics, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816901023709), received between Nov 20, 2023 and Dec 1, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (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. 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
- Fracture1
- Loss of or Failure to Bond1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2023Fracture; Fracture
AS THE LASER WAS BEING PULLED BACK THE FIBER BROKE OUT SIDE THE PATIENT 1/3 OF LENGTH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18251031 ↗MalfunctionNov 20, 2023Material Fragmentation; Material Fragmentation
FIBER DISLODGED IN PATIENT. DOCTOR REMOVED FIBER. PATIENT CONFIRMED UNHARMED.
Patient problems: Foreign Body In Patient
MAUDE report 18171278 ↗MalfunctionNov 20, 2023Loss of or Failure to Bond; Loss of or Failure to Bond
CONNECTOR DISENGAGED FROM FIBER BEFORE USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18171277 ↗
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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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