Kyocera Medical Technologies, Inc. S 100Recalls & reported problems
Kyocera Medical Technologies, Inc. · Straight Rod 5.5mm diameter 480mm length Ti6Al4V · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841523106974), received between Apr 12, 2017 and Apr 12, 2017 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Fracture1
- Improper or Incorrect Procedure or Method1
Patient problems
- Pain1
- Undesired Nerve Stimulation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 12, 2017Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method
ON (B)(6) 2017 RENOVIS SURGICAL TECHNOLOGIES CUSTOMER SERVICE (KJ) WAS NOTIFIED OF A COMPLAINT THAT 2 TITANIUM RODS USED IN A SPINAL FUSION SURGERY HAD FRACTURED AND REVISION SURGERY HAD BEEN PERFORMED TO REPLACE THE FRACTURED RODS.
Patient problems: Pain; Undesired Nerve Stimulation
MAUDE report 6486976 ↗
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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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