RAPHAEL Pedicle Screw System 015.3237Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841732119772), received between Oct 19, 2018 and Oct 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K132365); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2018Material Separation

  FOLLOW-UP MRI INDICATES THAT TULIP HAS SEPARATED FROM ROD. IN REVIEWING THE IMAGES, IT APPEARS THAT TULIP MAY HAVE SEPARATE FROM SCREW BODY. THE IMPLANTED DEVICE WAS NOT REMOVED, REVISION SURGERY DID NOT OCCUR. THE PATIENT IS DOING FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7987311 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132365. One submission often covers many models, so check the product and lot details in each record.

• Z-1030-2019 · Jul 5, 2018 · Terminated
  CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
• Z-1031-2019 · Jul 5, 2018 · Terminated
  CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050