X-CORERecalls & reported problems across all models
Nuvasive, Inc. · 29 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one X-CORE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 1
We found 29 models of X-CORE by Nuvasive, Inc. in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Jan 18, 2016 and Mar 5, 2026 — classified as 7 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Collapse” (6 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
X-CORE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 10, 2022Open, Classified
Potential that insert will be unable to disengage from the vertebral body replacement device/implant
Z-0738-2023 · Root cause: Device Design · names 6 of these models · Recall details · FDA record ↗
Most reported X-CORE problems
Device problems
- Collapse6
- Failure to Advance5
- Mechanical Jam5
- Device Slipped4
- Fracture4
- Adverse Event Without Identified Device or Use Problem3
- Migration3
- Activation, Positioning or Separation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Failure of Implant9
- Insufficient Information4
- Pain3
- No Information2
- Unspecified Infection2
- Bone Fracture(s)1
- Pneumothorax1
X-CORE models
29 models, most reported first. Each model has its own page with its reports, recalls and device details.
- X-CORE 7160012SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180016SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180018SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7220016SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7220018SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180041ASPINAL VERTEBRAL BODY REPLACEMENT DEVICE4 reports
- X-CORE D7185100SPINAL VERTEBRAL BODY REPLACEMENT DEVICE3 reports
- X-CORE 7160022SPINAL VERTEBRAL BODY REPLACEMENT DEVICE3 reports
- X-CORE 7160025SPINAL VERTEBRAL BODY REPLACEMENT DEVICE3 reports
- X-CORE 7180033ASPINAL VERTEBRAL BODY REPLACEMENT DEVICE2 reports
- X-CORE 7110002ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- X-CORE 7180055SPINAL VERTEBRAL BODY REPLACEMENT DEVICE2 reports
- X-CORE 5962152SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- X-CORE 5962294SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- X-CORE 5964152SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- X-CORE 6184000SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- X-CORE 7180025ASPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- X-CORE 7180027ASPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- X-CORE 7160035SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- X-CORE 7160063SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- X-CORE 7180025SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- X-CORE 7180027SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- X-CORE 7180033SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- X-CORE 7180067SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- X-CORE 7220033SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 report
- X-CORE XCORE18Sterilization wrap containers, trays, cassettes & other accessories1 report
- X-CORE 7160022P2Spinal vertebral body replacement device - Cervical1 report
- X-CORE 7160025P2Spinal vertebral body replacement device1 report
Recent X-CORE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Failure to Advance
THE EXPANSION MECHANISM WITH GREEN CROWN APPEARS DAMAGED. THE INSERTER WILL NOT EXPAND IMPLANT. HAD TO SUBSTITUTE WITH DIFFERENT CAGE. THE PATIENT MAY HAVE HAD INTRA-OPERATIVE INJURY BUT NOT DIRECTLY LINKED TO LACK OF EXPANSION CAPABILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24523981 ↗InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT OPERATION ON (B)(6) 2025; FIXATION LEVEL: TH10 ¿ L3: PS, L1 :X-CORE, L2/3 PLIF. THE CONDITION WAS AN L1 BURST FRACTURE. THE SURGEON INSERTED COROENT LM INTO THE L2/L3 INTERVERTEBRAL SPACE BY PLIF AND PERFORMED POSTERIOR FIXATION FROM TH10 TO L3. AND THEN, THE SURGEON THEN CHANGED THE PATIENT'S POSITION AND REPLACED THE L1 TO X-CORE VIA AN ANTERIOR APPROACH. DURING THE SURGERY, THERE WAS MINIMAL BLEEDING AND THE PATIENT'S VITAL SIGNS WERE STABLE. HOWEVER, THE PATIENT BUT DID NOT REGAIN CONSCIOUSNESS AND EXHIBITED OCCASIONAL CONVULSIONS. CT SCANS WERE PERFORMED FROM THE HEAD (INCLUDING THE IMPLANT SITE) TO THE ABDOMEN, BUT THE SURGEON COULD NOT IDENTIFY THE CAUSE. THE PATIENT TREATED IN THE ICU WHILE THE CAUSE IS BEING INVESTIGATED. ON (B)(6), THE PATIENT HAD AN MRI SCAN TO FIND THE CAUSE, AND THERE WERE NO FINDINGS IN THE BLOOD VESSELS AND IMPLANTS. WE DID NOT OBTAIN ANY COMMENTS REGARDING A CAUSAL RELATIONSHIP WITH OUR IMPLANTS AND MEDICAL DEVICES FROM THE SURGEON. THE SURGEON SUSPECTED NEUROLOGICAL DAMAGE DUE TO AN EPILEPTIC SEIZURE, CEREBRAL INFARCTION, OR PULMONARY EMBOLISM, BUT COULD NOT IDENTIFY THE CAUSE. ON (B)(6): THE PATIENT SHOWE
Patient problems: Insufficient Information
MAUDE report 23933826 ↗MalfunctionNov 3, 2025Failure to Advance; Failure to Advance
IT WAS REPORTED THAT DURING SURGERY THE X-CORE 2 FAILED TO EXPAND. THE SURGEON REMOVED IT AND IMPLANTED ANOTHER ONE. THIS EVENT OCCURRED IN ITALY.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 23457944 ↗MalfunctionSep 8, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE X-CORE FAILED TO EXPAND DURING A CASE AND ANOTHER IMPLANT WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22998433 ↗MalfunctionAug 29, 2025Structural Problem; Unintended Movement; Structural Problem; Unintended Movement
IT WAS REPORTED THAT A X-CORE CAGE HAD BEEN FOUND COLLAPSED POST-OPERATIVELY.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 22926621 ↗MalfunctionMay 1, 2025Use of Device Problem; Use of Device Problem
CAGE BROKE IN PATIENT AND HAD TO PULL IT OUT AND USE ANOTHER CAGE. NO ADVERSE EFFECTS TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21945799 ↗MalfunctionFeb 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2019, A PATIENT UNDERWENT A CORPECTOMY PROCEDURE AT T9/11. ON (B)(6) 2024, THE PATIENT REPORTEDLY EXPERIENCED SUDDEN PAIN, RADIOGRAPHS INDICATED DISLOCATION OF ONE ENDPLATE FROM THE CORE. ON (B)(6) 2025, A REVISION TOOK PLACE INCLUDING REMOVAL AND REPLACEMENT.
Patient problems: Pain
MAUDE report 21437802 ↗InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT WHILE A DEVICE WAS BEING IMPLANTED DURING A VERTEBRAL BODY REPLACEMENT SURGERY THE PATIENT DEVELOPED A SUSPECTED PNEUMOTHORAX, WHICH REQUIRED THE PLACEMENT OF A CHEST TUBE TO TREAT. NO INFORMATION WAS PROVIDED ON HOW THE PNEUMOTHORAX OCCURRED. NO INFORMATION ON THE PATIENT'S CURRENT CONDITION WAS PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Pneumothorax
MAUDE report 20929537 ↗MalfunctionDec 4, 2024Failure to Advance; Failure to Advance
IT WAS REPORTED THAT DURING A PROCEDURE THE CORE OF AN IMPLANT DID NOT EXPAND ONCE IN PLACE. THE CORE WAS REPLACED WITH ANOTHER AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO FURTHER CASE IMPACT AND NO IMPACT TO THE PATIENT. NO ADDITIONAL INFORMATION OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20849266 ↗MalfunctionJul 25, 2024Collapse; Collapse
ON (B)(6) 2024 A PATIENT RECEIVED VERTEBRAL BODY REPLACEMENT (VBR) IMPLANTED AT L3 WITHOUT ANY REPORTED ISSUE. ON (B)(6) 2024 THE X-CORE WAS IDENTIFIED AS COLLAPSED AND A REVISION PROCEDURE TOOK PLACE WHEREIN THE X-CORE IMPLANT WAS RE-EXPANDED AND THE LOCK SCREW WAS REPLACED. ON (B)(6) 2024 THE X-CORE WAS OBSERVED COLLAPSED A SECOND TIME AND A REVISION WAS SCHEDULED. ON (B)(6) 2024 THE X-CORE WAS EXPLANTED AND A NEW ONE X-CORE WAS PLACED AT L3. NO ADDITIONAL ISSUES REPORTED. (REPORT 2 OF 2, FOR REVISION ON (B)(6) 2024)
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19832105 ↗MalfunctionJul 25, 2024Collapse; Collapse
DEVICE RETURN INFORMATION AND UPDATES LISTED ON H10.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19832101 ↗MalfunctionMar 11, 2024Mechanical Jam; Mechanical Jam
DURING A SPINAL PROCEDURE THE INTERBODY WAS PLACED ON L1, BUT COULD NOT BE EXPANDED. IT WAS REMOVED AND REPLACED WITH NO ADDITIONAL ISSUES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18881867 ↗MalfunctionJan 30, 2024Mechanical Problem; Device Damaged by Another Device; Activation Problem; Mechanical Problem; Device Damaged by Another Device; Activation Problem
ON (B)(6) 2023 A PATIENT UNDERWENT A VERTEBRAL INTERBODY REPLACEMENT PROCEDURE AT L1-2 ONCE BEING PLACED INTO THE DISC SPACE THE IMPLANT WAS UNABLE TO EXPAND. THE SURGEON WAS ABLE TO EXPAND THE IMPLANT OUTSIDE OF THE PATIENT WITHOUT ISSUE BUT ONCE REINSERTED INTO THE DISC SPACE, THE IMPLANT WOULD NOT EXPAND. THE INSERTER HANDLE WAS STILL ABLE TO ROTATE, HOWEVER THE IMPLANT WOULD STILL NOT EXPAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18608339 ↗MalfunctionOct 18, 2023Mechanical Jam; Mechanical Jam
SCRUB TECH BROKE EXPANSION MECHANISM IN CORE AND WILL NOT EXPAND FROM STARTING HEIGHT WHEN PLACED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17960392 ↗MalfunctionSep 28, 2023Mechanical Jam; Mechanical Jam
DURING A SPINAL PROCEDURE AT LEAST ONE OF THE TWO CORES WAS DISTRACTED EX-SITU, THEN IMPLANTED AND COULD NOT BE DISTRACTED IN-SITU. THERE WAS NO REPORTED ADVERSE IMPACT TO PATIENT OR CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17838598 ↗
Other Nuvasive, Inc. products
All Nuvasive, Inc. devices →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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