CRESCENT Spinal SystemRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 0
We found 18 models of CRESCENT Spinal System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Nov 24, 2016 and Nov 7, 2025 — classified as 7 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Break” (39 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CRESCENT Spinal System problems
Device problems
- Break39
- Material Fragmentation4
- Fracture2
- Material Deformation2
- Adverse Event Without Identified Device or Use Problem1
- Crack1
- Migration or Expulsion of Device1
Patient problems
- No Known Impact Or Consequence To Patient20
- No Clinical Signs, Symptoms or Conditions14
- Device Embedded In Tissue or Plaque7
- No Consequences Or Impact To Patient6
- Cerebrospinal Fluid Leakage1
- Pain1
- Unspecified Infection1
CRESCENT Spinal System models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CRESCENT™ Spinal System 9393010Intervertebral fusion device with bone graft, lumbar10 reports
- CRESCENT™ Spinal System 9393008Intervertebral fusion device with bone graft, lumbar7 reports
- CRESCENT™ Spinal System 9393012Intervertebral fusion device with bone graft, lumbar6 reports
- CRESCENT™ Spinal System 9393007Intervertebral fusion device with bone graft, lumbar3 reports
- CRESCENT™ Spinal System X0912057Intervertebral fusion device with bone graft, lumbar3 reports
- CRESCENT™ Spinal System 9392507Intervertebral fusion device with bone graft, lumbar2 reports
- CRESCENT™ Spinal System 9392508Intervertebral fusion device with bone graft, lumbar2 reports
- CRESCENT™ Spinal System 9393607Intervertebral fusion device with bone graft, lumbar2 reports
- CRESCENT™ Spinal System 9393608Intervertebral fusion device with bone graft, lumbar2 reports
- CRESCENT™ Spinal System 9393612Intervertebral fusion device with bone graft, lumbar2 reports
- CRESCENT™ Spinal System 7968812Intervertebral fusion device with bone graft, lumbar2 reports
- CRESCENT™ Spinal System 9392509Intervertebral fusion device with bone graft, lumbar1 report
- CRESCENT™ Spinal System 9392510Intervertebral fusion device with bone graft, lumbar1 report
- CRESCENT™ Spinal System 9392511Intervertebral fusion device with bone graft, lumbar1 report
- CRESCENT™ Spinal System 9392512Intervertebral fusion device with bone graft, lumbar1 report
- CRESCENT™ Spinal System 9393009Intervertebral fusion device with bone graft, lumbar1 report
- CRESCENT™ Spinal System 9393011Intervertebral fusion device with bone graft, lumbar1 report
- CRESCENT™ Spinal System 7968212Intervertebral fusion device with bone graft, lumbar1 report
Recent CRESCENT Spinal System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MINIMALLY INVASIVE SPINAL FUSION. IT WAS REPORTED THAT THE CRESCENT INTERVERTEBRAL DISC WAS FOUND TO BE BROKEN. THE EVENT OCCURRED INTRA-OPERATIVELY, AND THE PRODUCT WAS NEVER IMPLANTED. NO FRAGMENTS REMAINED IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS, COMPLICATIONS, TREATMENT, OR ADDITIONAL SURGERY REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23494466 ↗MalfunctionApr 20, 2025Break; Break
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING SPINAL FUSION (L3-L4). IT WAS REPORTED THAT DURING A SPINAL FUSION SURGERY, THE DISC BROKE WHEN CLOSED INTO THE INTERVERTEBRAL SPACE AT THE L3-L4 LEVEL. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT, AND NO ADDITIONAL TREATMENT OR SURGERY WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21870232 ↗MalfunctionFeb 24, 2025Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING AN IMPLANTED DI SC. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED AND BROKE. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21444640 ↗MalfunctionJan 5, 2025Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH SPACER INVOLVED IN A POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE. IT WAS REPORTED THAT IMPLANT BROKE DURING PROCEDURE AND IMPLANTATION PROCESS. LATER, IT WAS TAKEN OUT. PRODUCT CAME IN CONTACT WITH PATIENT. THEIR WAS A DELAY OF ABOUT 1 HOUR IN THE PROCEDURE. PRE-OPERATIVE DIAGNOSIS FOR THE PATIENT WAS LUMBAR DISC HERNIATION. NO ADVERSE EVENT OCCURRED TO PATIENT. THE PATIENT¿S MEDICAL HISTORY INCLUDED LUMBAR DISC HERNIATION. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21075783 ↗MalfunctionDec 30, 2024Break; Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR FUSION FOR LUMBAR DISC HERNIATION. IT WAS REPORTED THAT THE SPACER BROKE INTRA OPERATIVELY. THE SPACER PARTIALLY EXPLANTED AND WILL BE RETURNED. THERE WERE FRAGMENTS OF THE IMPLANTS REMAINED IN THE PATIENT'S BODY. THERE IS NO PLAN OF ADDITIONAL SURGERY OR MEDICAL INTERVENTION TO REMOVE THE FRAGMENTS FROM PATIENT BODY. TRIED TO REMOVE AS MUCH AS POSSIBLE DURING THE SURGERY, AND WOULD NOT PERFORM A SECOND SURGERY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21032986 ↗MalfunctionDec 28, 2024Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT WHICH IS USED IN TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SPINAL THERAPY FOR L45 HERNIATED DISC AND LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT THE CAGE WAS BROKEN. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21031497 ↗MalfunctionNov 14, 2023Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN A NTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL THERAPY. IT WAS REPORTED THE CAGE CRACKED WHEN FIRST SCREW WAS INSERTED. THERE WERE NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT AND NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE ARE NO ISSUES WITH THE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18129740 ↗MalfunctionOct 6, 2022Break; Break
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIA GNOSIS FOR L2-L3 STENOSIS. PROCEDURE OR TECHNIQUE USED WAS TLIF. LEVELS IMPLANTED L2/L3. IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS GOING TO IMPLANT THE PRODUCT WHICH WAS HELD ON CAGE HOLDER. THE IMPLANT WAS BROKEN. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15548583 ↗MalfunctionSep 26, 2022Material Fragmentation; Material Fragmentation
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN TRANSFORAMINAL INTERBODY LUMBAR FUSION(TLIF). IT WAS REPORTED THAT THE IMPLANT WAS BROKEN. PATIENT MEDICAL HISTORY: LUMBAR 4/5 DISC HERNIATION. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS L45 SPINAL STENOSIS, INTERVERTEBRAL DISC HERNIATION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WERE NO ADDITIONAL SURGERY OR TREATMENT PERFORMED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE ALLEGATION WAS PRODUCT FRAGMENTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15484129 ↗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 ↗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 ↗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 ↗MalfunctionJun 21, 2021Crack; Crack
INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ALIF DUE TO UNKNOWN INDICATION. IT WAS REPORTED THAT THE SOVEREIGN GRAFT CRACKED AS SCREWS WERE BEING INSERTED. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12030797 ↗
Other Medtronic Sofamor Danek, Inc. products
- CD HORIZON Spinal System342 models · 2,323 reports
- GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)25 models · 12 reports · 14 recalls
- METRx System5 models · 672 reports
- INFUSE Bone Graft6 models · 576 reports · 1 recall
- CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
- POWEREASE Instruments8 models · 331 reports · 1 recall
- Catalyft PL Expandable Interbody System16 models · 279 reports · 1 recall
- INFINITY Occipitocervical Upper Thoracic System35 models · 63 reports · 5 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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