Kyocera Medical Technologies, Inc. S 150 (REF 1055-161-306)Recalls & reported problems
Kyocera Medical Technologies, Inc. · SA Cervical Cage, 16mm x 13.5mm x 6mm, 7° Lordosis, T3 · 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 00841523118250), received between Mar 22, 2017 and Mar 22, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 22, 2017Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
SALES REP FOR S1 SPINE (GL) INFORMED RENOVIS CUSTOMER SERVICE (KJ) OF A PRODUCT COMPLAINT ON 02/23/2017. THE COMPLAINT PERTAINS TO A S150 STAND-ALONE ANTERIOR CERVICAL INTERBODY FUSION 3-LEVEL CONSTRUCT, WHICH IS A CONTRAINDICATION TO THE IFU. THE COMPLAINT WAS REPORTED TO RENOVIS AFTER A ROUTINE 6-MONTH FOLLOW-UP EXAMINATION. AN X-RAY REVEALED A DISLODGED COVER PLATE AND TWO BACKED-OUT SCREWS ON THE MOST INFERIOR CAGE OF A 3-LEVEL FUSION. ACCORDING TO THE SURGEON, THE PATIENT IS ASYMPTOMATIC AND ALL 3 LEVELS HAVE FUSED. THERE ARE NO CURRENT PLANS TO RE-OPERATE AS THE COVER PLATE APPEARS FULLY CAPTURED IN THE DISC SPACE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6426074 ↗
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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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