CRESCENT™ Spinal System 9393010Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994187628), received between Oct 9, 2018 and Aug 4, 2022 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2022Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL PRODUCT USED IN TRANSFO RAMINAL LUMBAR INTERBODY FUSION (TLIF) THERAPY FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE FUSION CAGE WAS FRAGMENTED, AND ONLY THREE FRAGMENTS HAD BEEN TAKEN OUT, AND THE REMAINING PARTS HAD NOT BEEN TAKEN OUT. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO SECOND SURGERY PLAN AS THE AMOUNT OF BONE GRAFT WAS INCREASED INCREASED DURING SURGERY TO COMPACT THE FUSION CAGE AND PREVENT THE FRAGMENTS FROM FALLING OUT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15162177 ↗
• MalfunctionNov 29, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING TLIF SPINAL PROCEDURE. THE PRE-OP DIAGNOSIS WAS MENTIONED AS "LUMBAR CANAL STENOSIS". IT WAS REPORTED THAT, THE CAGE WAS BROKEN. THERE WERE NO FRAGMENTS OF BROKEN CAGE REMAINS IN PATIENT. THERE WERE NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED AND NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT.  THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12880924 ↗
• MalfunctionNov 15, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR LUMBAR SPINAL STENOSIS. PROCEDURE OR TECHNIQUE USED WAS TLIF. IT WAS REPORTED THAT DURING THE PROCEDURE AND IMPLANTATION OF THE FUSION DEVICE, THE FUSION DEVICE WAS BROKEN AND DAMAGED. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12817905 ↗
• MalfunctionOct 21, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF LUMBAR DISC HERNIATION INVOLVED IN THE TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, PRODUCT BROKE. PART OF IT REMAINED IN THE PATIENT'S BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. PRODUCT WAS USED UTILIZED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/ LABELING. PATIENT IS ALIVE AND NO INJURY. ON (B)(6) 2021, RECEIVED ADDITIONAL INFORMATION THAT BROKEN PART WAS DIFFICULT TO REMOVE. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR ONE HOUR. ON (B)(6) 2021, RECEIVED ADDITIONAL INFORMATION THAT EXTENDING THE TIME WAS MAINLY TO TAKE THE BROKEN FUSION DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12670153 ↗
• MalfunctionJan 11, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH LUMBAR DISC HERNIATION SUGGESTED FOR SPINAL THERAPY. PROCEDURE USED WAS LUMBAR DISC DECOMPRESSION, FUSION AND INTERNAL FIXATION. EVENT OCCURRED INTRA-OP. IT WAS REPORTED THAT THE CAGE BROKE DURING IMPLANTATION. THERE WERE NO FRAGMENTS LEFT IN PATIENT. IMPLANT WAS IMPLANTED AND EXPLANTED ON (B)(6) 2020. DEVICE IS BEING RETURNED. NO FURTHER PATIENT SYMPTOMS OR COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11145126 ↗
• MalfunctionDec 1, 2020Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SPACER USED IN LUMBAR DECOMPRES SION INTERVERTEBRAL FUSION AND INTERNAL FIXATION. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS LUMBAR CANAL STENOSIS. IT WAS REPORTED THAT AFTER THE FUSION WAS IMPLANTED IN THE INTERVERTEBRAL SPACE. ONLY PART OF IT WAS REMOVED AFTER IT WAS BROKEN, AND THE REMAINING PART OF THE FUSION WAS STILL IN THE PATIENT'S BODY. NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED. UPDATED INFORMATION RECEIVED ON (B)(6) 2020. DURING THE IMPLANTATION PROCESS OF THE FUSION DEVICE, THE FRACTURE OCCURRED WHEN TURNING AND KNOCKING. THE FUSION DEVICE WAS NOT REPLACED AFTER THE RUPTURE OCCURRED. SINCE THE REST OF THE DEVICE IN THE BODY WAS RELATIVELY INTACT AND WAS NOT TAKEN OUT, THE SURGERY WAS COMPLETED DIRECTLY. THE DOCTOR DIDN'T KNOW THE SPECIFIC REASON, AND IT HAD NOTHING TO DO WITH THE USE OR USE OF THE COMBINED EQUIPMENT DURING THE SURGERY. THE PATIENT IS CURRENTLY IN GOOD CONDITION AND HAS BEEN DISCHARGED FROM HOSPITAL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10926157 ↗
• MalfunctionMay 27, 2020Break; Break

  PRE-OPERATIVE DIAGNOSIS- SPINAL STENOSIS PROCEDURE- TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) IT WAS REPORTED THAT INTRA-OP, THE CAGE WAS BROKEN WHILE THE DOCTOR FILLED THE CAGE WITH BONE GRAFT ACCORDING TO THE PROCEDURE STANDARD. IT WAS REPLACED INTRA-OPERATIVELY. NO ANY FRAGMENTS OF THE IMPLANT REMAINING IN THE PATIENT BODY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10090569 ↗
• MalfunctionNov 25, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR DECOMPRESSION AND INTERNAL FIXATION DUE TO SPINAL STENOSIS. INTRA-OP, SPACER WAS BROKEN. NO ANY FRAGMENT OF THE IMPLANT WERE REMAINING IN THE PATIENT BODY. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9373780 ↗
• MalfunctionJun 12, 2019Break; Break

  PRE-OPERATIVE DIAGNOSIS: SPINAL DEGENERATION, DISC HERNIATION PROCEDURE: SPINAL INTERNAL FIXATION+FUSION SURGERY IT WAS REPORTED THAT INTRA-OP, IMPLANT WAS BROKEN WHILE INSERTION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8690793 ↗
• InjuryOct 9, 2018Break; Break

  PRE-OPERATIVE DIAGNOSIS: DEGENERATIVE DISC DISEASE (DDD) IT WAS REPORTED THAT INTRA-OP, CAGE WAS BEING INSERTED AND IT WAS BROKEN. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT BODY.

  Patient problems: Cerebrospinal Fluid Leakage; No Known Impact Or Consequence To Patient

  MAUDE report 7950129 ↗