CRESCENT™ Spinal System 9393012Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994187659), received between Nov 24, 2016 and Jul 29, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A POSTERIOR LUMBAR FUSION. IT WAS REPORTED THAT THE IMPLANT BROKE WHEN TAPPING IT. THERE WAS NO PATIENT SYMPTOM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127439 ↗
• MalfunctionMay 20, 2020Break; Break

  PRE-OPERATIVE DIAGNOSIS- L4-5 DISC HERNIATION, SPINAL STENOSIS PROCEDURE- TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) IT WAS REPORTED THAT INTRA-OP, THE CAGE BROKE WHILE IMPLANTATION. THE DOCTOR KNOCKED THE HOLDER AND WANTED TO IMPLANT THE CAGE INTO THE INTER VERTEBRAL SPACE, RESULTING IN CAGE FRAGMENTATION. CAGE WAS REMOVED INTRA-OPERATIVELY ITSELF. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10073889 ↗
• MalfunctionSep 24, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR LAMINECTOMY AND DECOMPRESSION, NUCLEUS PULPOSUS EXPLORATION AND REMOVAL, INTERNAL FIXATION THROUGH THE PEDICLE SYSTEM, SPONDYLOLISTHESIS REDUCTION, INTERVERTEBRAL FUSION AND BONE GRAFT FUSION DUE TO LUMBAR SPONDYL OLISTHESIS, LUMBAR SPINAL STENOSIS, OSTEOARTHRITIS AND CHRONIC PELVIC INFLAMMATORY DISEASE. INTRA-OP, WHEN HALF OF THE IMPLANT WAS DRIVEN INTO THE FUSION CAGE, PROSTHESIS GOT CRACKED AND THE HOLDING PART BROKE BECAUSE OF WHICH ALL THE IMPLANTS WERE REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9108004 ↗
• MalfunctionJan 9, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH LUMBAR DISC HERNIATION, SPINAL STENOSIS AND UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY. DURING SURGERY, THE SPACER WAS BROKEN WHILE IMPLANTING INTO THE PATIENT. THE SURGEON TOOK OUT THE BROKEN SPACER AND REPLACED IT WITH THE SAME TYPE OF SPACER FOR NORMAL IMPLANTATION. THERE WAS NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8230396 ↗
• MalfunctionApr 21, 2017Break; Break

  PRE- OP DIAGNOSIS: LUMBAR DEGENERATION IT WAS REPORTED THAT DURING SURGERY, SPACER WAS FOUND TO BE RUPTURED. THE SURGERY WAS SUCCESSFULLY COMPLETED BY REPLACING THE PRODUCT WITH A NEW ONE. NO PATIENT COMPLICATION WAS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6510537 ↗
• MalfunctionNov 24, 2016Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT SURGERY DUE TO INTERVERTEBRAL DISC DEGENERATION. INTRA-OP, THE SPACER BROKE AND WAS REPLACED BY A NEW ONE TO COMPLETE THE SURGERY. NO FRAGMENTS OF THE PRODUCT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6126709 ↗